w w w . n u t r a c e u t i c a l m a g . c o m

Volume 8 Number 1 January/February 2012

• ingredients • functional foods • nutraceuticals • supplements • raw materials •

NATURAL SWEETENERSWelcoming a new eraA sweet escape

ESSENTIAL FATTY ACIDSTaking the flaxProtecting the platform

EXAMINING ECHINACEA

FROM FARMER TO PHARMA

BONE & JOINT HEALTH

Walking on eggshellsA holistic approach

intera 210x297 iodine.indd 1 12/12/11 12.55

03contents

32 Building Bones Stronger, for LongerKimberly J. Dekker

36 A Holistic Approach to Joint HealthDr Joosang Park

40 Bone BoomLu Ann Williams

42 A Joint EffortCharlotte Frederiksen

Weight Management44 Intuitive NutritionVladimir Shkolnikov

Industry Issues46 Without a Safety NetGeorge Pontiakos

Last Word48 From Farmer to PharmaTim Jones and Caroline Dewing

Regulatory Review50 Finding the Needle in the HaystackDr Cheri Turman

0303Volume8 Issue1

2430

48

Guest Editorial04 Nutraceuticals: How Pharma Can Get a Share of the MarketLeonard M. Fuld

News06 The Latest News and Updates

GOED Report10 Oxidation of EPA and DHA Oils: The Controversy ContinuesAdam Ismail and Harry Rice

Herbals and Botanicals12 Examining Echinacea Part IDr Nancy J. Szabo

Essential Fatty Acids18 The Alpha to Omega of KrillHenrik Traaholt

20 Protecting the PlatformDr Kevin Robinson with Dr Wael Massrieh

21 Taking the FlaxEric Bochardt

Natural Sweeteners24 A Sweet EscapeRony Van Den Abbeele

28 Welcoming a New EraHenry Hussel

Bone and Joint Health30 Walking on EggshellsHeather Thompson

January/February2012Contents1804

www.nutraceuticalmag.comJanuary/February 2012

28

22

12

20

www.nutraceuticalmag.com January/February 2012

04guest editorial

The pharmaceutical industry is in danger of ceding the large and

growing nutraceutical market to the consumer packaged

goods (CPG) companies. Thus predicts The Battle for Designer

Foods, a public war game in which four teams from top business

schools were tasked with stress-testing the nutraceutical strategies of

Abbott Labs, Danone, GlaxoSmithKline and Nestlé.

The global market for nutraceuticals — foods that, owing to addition or

enhancement, provide health benefits beyond nutrition — is projected to

be close to $250 billion by 2015, according to a report from Global Industry

Analysts. The change in landscape that appears to signal the end of the

era of the blockbuster drug and bring pharmaceutical companies face to

face with expiring patents and slim pipelines means that the nutraceutical

market could provide an alternative revenue stream — and a welcome one

at that. Rather than posing the question of “can pharma compete here?”

companies should instead ask what changes should be implemented by

pharma to compete, and refuse to allow the obvious advantages of CPGs

— such as strong track records in marketing foods directly to consumers

— and the inherent obstacles of pharma companies — particularly a

risk-averse culture borne of strict US Food and Drug Administration (FDA)

regulations — to prevent them from carving out a piece of this market.

This is not to overlook the challenge that pharmaceutical companies

must overcome to succeed; strict FDA regulations prevent them from

simply putting their drugs into consumer products (although nutraceuticals

are regulated by the FDA, they are subject to different restrictions). Their

traditional route to success, which encompasses a high reliance on

science, clinical trials, the protection of intellectual property and reaping

the benefits of years of patent protection, may have to be upended if

pharma is to succeed in the adjacent nutraceutical market. This hesitancy

could well be a classic case of what Clay Christensen describes as The

Innovator’s Dilemma, in which the high revenue-and-returns bar set by

large companies, and their reluctance to accept anything less, hinders

innovation — pharma companies are accustomed to much higher product

margins than packaged food companies. Having invested billions in

researching drugs that treat or prevent diseases, will pharma companies

be satisfied with something as apparently simple and relatively low-margin

as probiotic yoghurts, scientifically engineered nutritional drinks or even

heart-healthy breakfast spreads?

Solutions of this kind, promising profits that exceed typical packaged

food products, are part of what makes the opportunity so appealing

for the CPGs, who boast great expertise in creating and marketing

mainstream products in addition to some experience in doing the same

with less sophisticated enhanced food products, such as vitamin water.

Food giants are beginning to make significant investment in this space;

October 2010 saw Nestlé announce its planned investment of more than

half a billion dollars in creating a standalone health science business to

pioneer a new industry between food and pharma.

Similarly, Danone has refocused its portfolio on nutrition during the

last decade, a key example of which is its $17 billion purchase of Royal

Numico, a leader in infant and clinical nutrition products. This deal, along

with its blockbuster Activia probiotic yoghurt, provides Danone with a

stronghold in the area of health and nutrition. The bottom line is that to

compete successfully, it will be necessary for pharmaceutical companies

to start thinking and acting like CPGs. The recent war game exercise gave

rise to some specific strategies that the pharmas can usefully employ.

Lose the Blockbuster MentalityThe extensive — and expensive — research, clinical trials and

formulation required to obtain FDA approval for drugs have paid off for

the pharmaceutical companies in the form of patent protection, IP and

a ready made distribution network of hospitals, doctors, formularies

and insurance systems. This has contributed greatly to the mentality of

relying on blockbuster drugs. Instead of looking for blockbuster-equivalent

nutraceutical products, the pharmaceutical companies should consider

taking smaller, measured steps and building a portfolio of products that

incorporate ingredients already approved by the FDA for use in foods such

as fish oils, sterols and stanols.

Make the Public Health CaseHigh cholesterol, diabetes, obesity and heart disease are among the most

serious and prevalent health risks in the developed world — and are all

conditions that can be affected by nutraceuticals. Making the public health

case is about solving a problem that already exists with proven ingredients

that don’t need drug-level approval.

Experiment Outside the LabPharmaceutical companies are accustomed to basing their experimentation

in the lab; indeed, it is at the very heart of what they do. There is, however,

an overarching need for this zeal to be redirected toward the marketplace;

companies must be willing to trial different enhanced-food products,

establish what customers will buy and realize that testing a food that may

bomb with consumers in one version and moderately succeed in another

is not the same as putting out a drug that is found to have severe side-

effects. The consumer marketplace for nutraceuticals may offer a different

risk-reward equation when testing for a winning product. Food companies

recognize this distinction and are constantly tinkering with packaging,

ingredients and brand extensions — although this is not always successful

(new Coke, anyone?). It is this flexibility and willingness to fail occasionally

that constitutes a part of their success.

Educate ConsumersDespite marketing directly to consumers, pharmaceutical companies

lack expertise in creating and exploiting a broad, populist market need.

NuTrACEuTICALsHOw PHArmA CAN GET A sHArE OF THE mArkET… and Avoid Being Blindsided by CPGs

www.nutraceuticalmag.comJanuary/February 2012

05guest editorial

Susanne FässlerMarketing Communication ManagerFrutarom Switzerland Ltd

Jörg GrünwaldPresidentAnalyze & Realize ag

Dr Michelle H. Jones Manager, Regulatory and Scientific Affairs Archer Daniels Midland Company

John KurstjensMarketing ManagerLipid Nutrition

Chris LeeEvent DirectorIIR Exhibitions

Ulla FreitasManagerScientific Affairs, NutritionLonza AG

Theodor GraserHead Pharma Industry DSM Nutritional Products Ltd

Denzil PhillipsFounderDenzil Phillips International

Pedro VieiraMarketing ManagerKemin Health Europe

Robin WardManaging DirectorExcelsa Pharmaceuticals Sagl

John Wilkinson Consultant Phytochemist and DirectorHerbal Sciences Int. Ltd

Dr Paul BerrymanChief ExecutiveLeatherhead Food International

Norbert WeitkemperManaging DirectorVital Solutions GmbH

To subscribeProfessionals working within the industries we cover may purchase a year’s subscription by sending a cheque for £100.00 made payable to Via Media UK Ltd, Wesley House, Bull Hill, Leatherhead, Surrey, KT22 7AH

No part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without permission.

Copyright © 2012, Via Media UK Ltd. All Rights Reserved

Volume 8 Issue 1January/February 2012 ISSN 1745-8307

ContributorsEditorial DirectorKevin Robinson+44 (0) 1392 202 591kevin.robinson@via-medialtd.com

Assistant EditorCharlotte Hodgson +44 (0) 1372 364 130 charlotte.hodgson@via-medialtd.com

Art Director/ProductionPaul Andrews +44 (0) 1372 364 126paul.andrews@via-medialtd.com

Web Design/MarketingClaire Day+44 (0) 1372 364 129claire.day@via-medialtd.com

General ManagerMiranda Docherty+44 (0) 1372 364 122miranda.docherty@via-medialtd.com

SalesGill Healy+44 (0) 1372 364 128gill.healy@via-medialtd.com

Financial OfficerCherelle Saunders+44 (0) 1372 364 123cherelle.saunders@via-medialtd.com

Editorial Advisory Board

The publisher endeavours to collect and include complete, correct and current information in Nutraceutical

Business & Technology, but does not warrant that any or all such information is complete, correct or current.

The publisher does not assume, and hereby disclaims, any liability to any person or entity for any loss or

damage caused by errors or omissions of any kind, whether resulting from negligence, accident or any other

cause. Nutraceutical Business & Technology does not verify any claims or other information appearing in any

of the advertisements contained in the publication, and cannot take any responsibility for any losses or other

damages incurred by readers in reliance on such content.

The key will be in raising consumer awareness about the efficacy

of non-medicinal products to manage certain health conditions,

conditions for which, in many cases, they are already deeply involved

in treating or preventing. The nutraceutical product simply provides

another approach to addressing the same problem.

Be Willing to Collaborate Although mergers will increase (Pfizer has recently announced its

willingness to sell a portion of its nutrition business), collaborations with

CPGs will likely be a key basis for success. This is also an area in which

pharmaceutical companies tend to be wary, afraid that the marketing,

packaging expertise and distribution channels of CPGs will put them at

a disadvantage in any deal. In the short-term, however, collaboration

may be the easiest and quickest way for them to enter the market.

All this should not suggest that the barriers to entry and potential

success are too high for pharmaceutical companies — they may be

better equipped than CPGs to endure the costly and time consuming

R&D required for more sophisticated products that the market may

eventually call for. There have been some limited Big Pharma success

stories; Abbott Labs is a leader in both child and adult nutraceuticals

with its high science Pedialyte and Ensure products. GSK Consumer

Healthcare has successfully launched several of its nutritional beverage

products in China and India, the revenue growth from which could

motivate the company to take a more aggressive approach with these

products in other markets, such as the US.

The size of the opportunity presented by this sector and

their need for fresh revenue streams are pressing reasons for

pharmaceutical companies to assert themselves in the market. It is

in collaboration that their best hope for success lies — borrowing

strategy, and perhaps even talent, from the CPGs. A shift in attitude

will also be needed; the risks may be greater, but so may the

rewards. To ignore the potential of this market would be a mistake

for an industry that can no longer rely on its former business model

as its only means of success.

On 30 April 2012, this war game will be acted out in the UK between

top business students from Oxford and Cambridge. It will take place

at Said Business School, University of Oxford, where students from

Cambridge Judge Business School, University of Cambridge, will

compete for the prize. It will be interesting to compare the predictions

made in the US in April 2011 with those resulting from this game.

For more informationLeonard M. Fuld CEOFuld & Company (www.fuld.com)To see excerpts of the Fuld & Company The Battle for Designer Foods war game, please visit www.fuld.com/Services/WarGames.html.

06news

The Next Generation of TexturizersFiE was the scene of Fiberstar Inc. (www.fiberstar.net) and Gum Technology’s announcement of their new partnership to create a revolutionary new line of texturizing ingredients. Combining the proven moisture management of Fiberstar’s Citri-Fi with highly functional hydrocolloid-based stabilizer blends from Gum Technology, the Hydro-Fi line presents a new generation of texturizers for baked goods, frozen desserts, meat products and sauces.

Designed to provide innovative, high performance solutions for specific food formulation challenges, the ingredient range also offers significant cost reductions and performance benefits for manufacturers, including increased moisture retention, extended shelf-life and improved yield and texture. Dale Lindquist, president and CEO of Fiberstar comments: “We’re really excited by today’s launch; the two companies’ combined expertise and ingredients have enabled the emergence of an entirely new line of texturizers. Amalgamating the textural benefits of hydrocolloids with the unique properties of citrus fibre presents a new generation of ingredients that provide advantages well beyond the proven performance of their individual constituents. He continued to emphasize the “almost limitless” potential of Hydro-Fi and Citri-Fi and claimed that the company is “keen to develop relationships with other ingredient manufacturers who would be interested in capitalizing on the ingredients’ unique water and oil retention performance in combination with their own ingredients.”

Investing for EvolutionIn 2011, PLANTEX, a French specialist in plant extracts, expended 15% of its turnover in its R&D department. According to its CEO, Mrs Debaisieux, the investment reflects the company’s “strong will to remain involved in emerging markets to improve and perfect the services offered to industrial partners,” and signals that it is “preparing for the future with a constant drive to anticipate each of our clients’ particular needs.” The company invests heavily in its organization, creating a clearly identified marketing service and enhancing its R&D to further improve its response to the high level of demand it is currently facing, particularly in the area of organic vegetal extracts.

Their production unit and laboratory are acquiring new and more efficient analysis and extracting equipment, including a third innovative spray drying tower and HPLC, which will increase production capacity. This will allow PLANTEX to address customers’ requests, some of which are urgent, with an even better flexibility and reliability, while maintaining the same quality and traceability (www.plantex.fr).

January/February 2012www.nutraceuticalmag.com

Positive Opinion on Reduchol Following an application by Slovenian functional ingredients producer Valens Int. (www.valens-health.com) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006, EFSA has recently delivered an opinion on the scientific substantiation of a health claim related to barley beta-glucans and the lowering of blood cholesterol and reduced risk of heart disease, referring to disease risk reduction and including a request for the protection of proprietary data. A cause-and-effect relationship has been established between the consumption of barley beta-glucans and the lowering of blood LDL-cholesterol concentrations. Several pertinent studies were provided in the health claim application, showing first that at doses of at least 3 g/day the ingredient produced a decrease in total and LDL cholesterol concentrations in both normo- and hypercholesterolaemic subjects and, second, that there is evidence supporting the biological plausibility of the mechanism of the effect. Based on this scientific data, at least 3 g of barley beta-glucans should be consumed per day to obtain the claimed effect; in practice, this could be divided into smaller portions.

Following huge investment, Valens Int. regards this as an important success, which will enable even stronger health claims for producers using Reduchol in a wide range of food products. Furthermore, this opinion gives the company a competitive advantage when it comes to marketing its product. The health claim application was submitted in May 2011 and the prompt and supportive communication with EFSA should be noted. During the evaluation process, Valens Int. delivered all requisite data on time and no stop-the-clock procedures were called for, which the company believes to be owing to the high quality of the health claim application, prepared with scientific support from the Nutrition Institute (Ljubljana, Slovenia).

Natural Shelf-Life and Yield Management SolutionVitiva has recently introduced VFish, a new product line of natural solutions for increasing the shelf-life and yield management of processed fresh fish. VFish is a unique combination of natural, mineral-rich sea salt combined with Vitiva’s proprietary plant extract formulations. This ready-to-use new formula provides full antirancidity and yield increase and supports antimicrobial stability for prepared fish and fish products. Water-binding capacity is one of the key parameters of processed fish and has a significant impact on the yield and juiciness of the final product; most physical properties, including the colour, texture and firmness of raw fish result from water this capacity. In addition, fish and fish products contain high amounts of healthy polyunsaturated fatty acids (PUFA) and thus are prone to rapid oxidation and rancidity. Lipid oxidation, coupled with microbial proliferation, is a major cause of deterioration and spoilage for fish.

As it affects the succulence and tenderness of the finished products as well as economic aspects of the operation, monitoring water-binding capacity is priority for the fish industry. Ohad Cohen, CEO of Vitiva, commented: “VFish is an excellent choice for food processors desiring to improve seafood water-binding capacity without the addition of phosphates and still control rancidity and microbial instability. Moreover, this completely natural product line enables fish processors to employ clean-label solutions for their products, while gaining extensive shelf-life and avoiding synthetic ingredients that might have the potential for harm.” Fish producers may choose among different customized VFish formulations, which are applicable to both mainstream and organic-certified products. The new line is available as a dry mix complete solution that is customized to different batch sizes, various technological needs and processing operations. Vitiva is a leading, fast growing and innovative company that provides advanced, application-specific solutions based on natural extracts for all food, cosmetic, pharmaceutical and nutraceutical industries (www.vitiva.eu).

For more information on our award-winning ingredients, visit capsimax.com or lutemax2020.com.

©2011 OmniActive Health Technologies

OmniActive Health Technologies continues to receive global recognition

and acclaim. Recently, OmniActive received two awards for ingredient

and technology innovation.

Capsimax™ and Lutemax 2020™ showcase OmniActive’s breakthrough

technologies and formulations that enhance the body's ability to absorb

and utilize health promoting ingredients. By delivering nutrients in

bioavailable, scientifically validated and stable forms we provide our

valued customers with the innovative partnership they require to develop

truly outstanding consumer products.

omniactives.com

The Frost & Sullivan 2011 Global Eye Health Ingredients (Lutein & Zeaxanthin) Product Differentiation Excellence Award

Nutrition Business Technology Award for Most Innovative Ingredient, presented at Vitafoods

Thank you for noticing.

C

M

Y

CM

MY

CY

CMY

K

Omni-Awards-NBT.pdf 1 10/19/11 11:31 AM

January/February 2012www.nutraceuticalmag.com

08news

Beta-Glucan BenchmarkNorwegian life science company, ImmunoMedic, has announced that it is preparing to launch its ultra pure beta 1,3/1,6 glucan ingredient, Betox-93, in the North American market. Betox-93 yields one of the highest levels of purity in the market — 93% — in addition to the higher bioavailability that results from high purity and micronization of particles, making it suitable for a wide range of formulations.

Beta-glucan is a complex sugar molecule, or polysaccharide, primarily used to stimulate the immune system as well as to manage levels of blood cholesterol concentration. The most common source of beta-glucans are higher fungi, baker’s yeast cell walls and grains of some cereals. Morten Sundsto, president and CEO of ImmunoMedic, described the company as “thrilled to bring this new, high purity and high bioavailability beta-glucan to he North American market,” which he claimed is “expected to grow rapidly in the coming years.” He continued: Beta-glucan is increasingly gaining attention as a natural and effective ingredient for a wide range of applications, including supplements, functional foods, skincare and wound care.”

Free from any proteins, fats, taste or odour, the patented ingredient is produced under strict quality control from its origin of certified organic oyster mushroom (Pleurotusostreatus, hiratake). Beta-glucan is the most studied natural immunostimulator there is, boasting more than 10,000 published studies. As the next development and commercialization phase, ImmunoMedic is identifying distribution partners and key customers in the North American market (www.immunomedic.com).

Kaneka Wins Novel Food ApprovalFollowing a thorough regulatory and safety inspection process by EFSA, Glavonoid — a functional ingredient that, thanks to its ability to activate the body’s fat metabolism and suppress fat synthesis, offers unique dual support in fighting visceral fat — has been granted novel food status by the European Commission. Derived from liquorice root (Glycyrrhiza glabra L.) using an advanced patented process, Glavonoid is absolutely free from glycyrrhizinic acid, contains 30% liquorice glabra polyphenols and is standardized on 3% Glabridin, its major active component. Its power to support visceral fat reduction has been proven — in DNA microarray analysis, the ingredient exhibited a two way efficiency mechanism: on the one hand it increases the body’s own fat burning ability by up-regulating genes involved in fatty acid oxidation, and on the other it decreases fat synthesis by down-regulating genes that are involved in fatty acid synthesis.

The liquorice root extract can be used in supplements as a single ingredient or as part of a multicomponent system and is also suitable for use in beverages based on milk, yoghurt, fruit or vegetables. Its novel food status provides manufacturers with a new health ingredient for building slimming and weight management products, especially those that target visceral fat reduction. Possible claims for such products would principally be aimed at slimming, a healthy BMI, boosting fat metabolism and supporting weight management, but could also target the sport and fitness and healthy ageing markets. A spokesperson from Kaneka commented: “After the complex EFSA regulatory process, we are very pleased that Glavonoid has received novel food status. Weight management is now a major issue and, as visceral fat is a main risk factor for the development of metabolic syndrome, we see an extremely promising market here.” Glavonoid has been sold in Japan and the US for several years, having achieved NDI status in 2005 and FDA GRAS status in 2008. The new novel food status refers to the general adult population and a 120 mg daily consumption of Glavonoid in milk, yoghurt, fruit or vegetable based beverages or food supplements (www.kanekapharma.com).

Natural Colours for Use in Oral Dosage FormsManufacturers of nutraceutical oral dosage forms now have more coating choices, thanks to the launch of the Aquarius coatings natural colour palette from Ashland Specialty Ingredients, a commercial unit of Ashland Inc. (www.ashland.com). Label friendly and in compliance with food regulations, these coating systems use colourants based on natural ingredients that are colour stable under light and storage conditions. Available in a spectrum of hues, the new palette increases Ashland’s nutraceutical offerings and clearly designates solutions that comply with regional and global regulations. This new range was developed in response to market demand for natural coatings that are in compliance with changing regional regulations for nutraceutical products. “Nutraceuticals are subject to food regulations, which are more restrictive than their pharmaceutical counterparts regarding the colorants permitted for use in tablet coating systems,” said Laurie Kronenberg, Ashland’s new product leader of pharmaceutical and nutrition specialties, “and we anticipate that more colourants may come under future use restrictions.”

Ashland has responded to differing compliance requirements for colourants in major markets by providing a broader colour palette for their tablet coating systems, which addresses regional regulatory requirements. Iron oxides, for instance, are permitted in pharmaceutical and food applications in the EU, but only for inclusion in pharmaceuticals in the US. Dr Tom Durig, technical director of pharmaceutical and nutrition specialties, explained: “We have recognized that, historically, natural colourants have not generally been perceived as colour stable, especially with regards to light stability. Through comprehensive and quantitative light storage colour stability testing our scientists were able to eliminate these from our tablet coating systems.”

www.nutraceuticalmag.com January/February 2012

10 GOED report

In the last issue of nutraceutical business & technology, GOED reported on the

controversy associated with oxidation of

the long-chain omega-3 oils. Admittedly,

this is a contentious issue, but when

GOED’s last column went to press, both

the European Food Safety Authority (EFSA)

and the Norwegian Scientific Committee for

Food Safety (VKM) were of the opinion that

there was insufficient information available

to conclude qualitatively or quantitatively

that rancid fish oil intended for human

consumption was a hazard. In the absence of

supporting data, how can a scientific opinion

change? Although the how is unclear, what

is clear is that the VKM’s opinion appears to

have done just that: changed.

At the end of October, the VKM

published the second of its three reports,

in which the committee deployed a new

tone.1 The report focused on the risk

assessment of decomposition substances

and oxidation products in fish oils and,

similar to its previous conclusion on

oxidation found in the first report, the

VKM noted a lack of knowledge and

insufficient information upon which to

base a thorough risk assessment.2 What’s

curious, not to mention disturbing, is that

despite finding no supporting data, the

VKM concluded that concerns related to

the regular consumption of oxidized marine

oils warranted changes in consumer

behaviour. In remarks made on its website,

the VKM adds insult to injury by stating:

“Scientific Committee for Food (SCF) is

somewhat concerned about the negative

health effects that long-term intake of

oxidation products of supplementation with

fish oil may have.”3 The concern stems

from a small number of animal studies

demonstrating a “potential” negative health

effect from large doses of highly oxidized

vegetable oils. In other words, their

concerns about the safety of oxidized fish

oils in humans stem from tests that were

not performed on humans and that used

completely different products, which are

known to be burned in the body faster than

the fats in fish oils.

Although the VKM’s report notes a lack of

published scientific studies on the effects of

oxidation products on human health, results

from the first double-blind randomized

controlled study in humans have just been

published. They demonstrate no changes

in a variety of in vivo markers of oxidative

stress, lipid peroxidation or inflammation

after daily intake of 8 grams of oxidized fish

oil (equivalent to 1.6 grams of omega-3/

day) for 3 or 7 weeks, indicating that

intake of oxidized fish oil may not have

unfavourable short-term effects in healthy

human subjects.4

The VKM is a scientific body and as such

must substantiate its opinions with the

available scientific evidence: concern based

on an absence of science is conjecture

and only serves to confuse consumers.

In fact, after a recent report raised fears

about the consumption of oxidized fish

oils, Norwegian public health officials

were forced to announce on television

that consumers have no reason to worry

and that the products they are taking

are safe. GOED has also had to address

these issues at a symposium of healthcare

professionals in China! The third of VKM’s

three reports, which is yet to be published,

is a full risk and benefit assessment of

marine oils — hopefully all conclusions will

be scientifically substantiated.

We leave you with one last very important

piece of information. Oxidation — both in

general and as it relates to fat specifically

— typically carries negative connotations.

Thus, it’s no surprise that consumers and

many healthcare professionals believe

that oxidation is a bad thing. Keep in mind

that, first, oxidation of dietary fat is part of

normal metabolic homeostasis, secondly,

no study has ever shown that consumption

of oxidized fish oils is harmful and, thirdly,

that the omega-3 oils consumed around

the world are generally nowhere near

rancid anyway!

References1. Norwegian Scientific Committee for Food

Safety, Description of the processes in the value chain and risk assessment of decomposition substances and oxidation products in fish oils (http://www.vkm.no/dav/4be9bee090.pdf).

2. Norwegian Scientific Committee for Food Safety. Evaluation of negative and positive health effects of n-3 fatty acids as constituents of food supplements and fortified foods. (http://english.vkm.no/dav/031c000d1a.pdf).

3. http://vkm.no/eway/default.aspx?pid=277&trg=Content_6553&Content_6553=6187:1662070::0:6655:1:::0:0

4. I. Ottestad, et al., “Oxidised Fish Oil Does Not Influence Established Markers of Oxidative Stress in Healthy Human Subjects: a Randomised Controlled Trial,” British Journal of Nutrition. DOI: 10.1017/S0007114511005484. (2011)

For more informationAdam Ismail, Executive Director and Harry Rice, VP, Regulatory and Scientific AffairsGlobal Organization for EPA and DHA Omega-3s (GOED)1075 East Hollywood AvenueSalt Lake City, Utah 84105, USATel. +1 801 746 1413www.goedomega3.com

OxIDATION OF EPA AND DHA OILs THE CONTrOVErsy CONTINuEs

11strap

January/February 2012 www.nutraceuticalmag.com

C

M

Y

CM

MY

CY

CMY

K

epax_fish_ad_nbt_new.pdf 1 12/22/11 11:46 AM

www.nutraceuticalmag.com January/February 2012

12 herbals and botanicals

Adverse EventsAdverse event reporting for drugs, medical

devices and dietary supplement products

is recognized as an important means of

identifying signals that could have a direct

clinical impact on consumers. The Food and

Drug Administration (FDA) and Center for

Food Safety and Nutrition (CFSAN) defines

an adverse event as “any health-related

event associated with the use of a dietary

supplement that is adverse,” and a serious

adverse effect as “an adverse event that

results in death, a life-threatening experience,

inpatient hospitalization, a persistent or

significant disability or incapacity, or a

congenital anomaly or birth defect; or

requires, based on reasonable medical

judgment, a medical or surgical intervention

to prevent an outcome described above.”1,2

Identifying possible adverse events

associated with the use of a dietary

supplement product is accomplished by

conducting safety evaluations in preclinical

(namely, animal) testing, before monitoring for

adverse events in human clinical studies and

postmarketing surveillance. In the US, the

primary aim of a clinical study is to determine

efficacy — identifying adverse effects is

a secondary goal. Because clinical trial

data are obtained under strictly controlled

conditions, this signal detection mechanism

is very sensitive. Identifying and following

evolving adverse events for supplement

products may also be achieved through

postmarketing surveillance, which has two

significant advantages over clinical trials: it

provides ongoing surveillance of all users

(as opposed to the small sample size in a

clinical trial) and is relatively inexpensive as

a process.3

Echinacea ProductsThe genus Echinacea (Family Asteraceae)

comprises about a dozen species of

herbaceous perennials, indigenous

throughout the eastern and central US and

southern Canada. The three most commonly

used species in supplemental preparations

are Echinacea angustifolia, E. purpurea and E. pallida. Fresh and dried roots and

aerial parts, and fresh-pressed juice from

flowering tops, are prepared into tinctures,

teas, juices, powders, tablets or capsules

that may also contain additional ingredients,

some of which may be botanical. In the US

and Canada, Echinacea-containing products

are marketed as dietary supplements, which,

by definition, are for oral administration only;

intravenous (IV) products for use in medical

settings are common in other countries,

including Germany.4 Regardless of final

form, Echinacea-containing preparations are

used by consumers primarily because they

are perceived as having immunostimulant

properties. Of all the dietary supplements

currently available, Echinacea-containing

preparations are among the most popular,

being sixth in USA sales in 2008.5

Few safety studies for Echinacea

preparations are available in scientific

literature, possibly because the flowering

herb has an exceptionally long history of

safe use. Echinacea has been used since at

least the eighteenth century by native North

Americans to assist in wound healing, as

a remedy for infection and toothache, as

a means of alleviating joint pain and as an

antidote for snakebite — and, until modern

antibiotics replaced most herbal remedies,

Echinacea preparations were also in regular

use by the general US population, primarily

as anti-infective agents. 5-10

PreClinical StudyIn one published safety evaluation,

the toxicological effects of orally and

intravenously administered fresh-pressed

E. purpurea juice (also known as Echinacin or

Echinaguard — 1 mL of the unpurified juice

is equivalent to 1.5–2.5 g of crude Echinacea

ExAmINING ECHINACEAAccess to safe and efficacious dietary supplements is an important part of a personal health

and wellness regimen that is pursued by many US and Canadian consumers. Of the dietary

supplements available, Echinacea-containing preparations — the sixth best selling in the

US — are among the most popular. Broadly viewed as an immunostimulant by consumers,

Echinacea is primarily taken to decrease the risk of contracting colds, flu and generalized

upper respiratory infections, to shorten the duration and severity of such illnesses and

to otherwise boost the immune system prophylactically. To ensure that consumers have

continued access to safe dietary supplements, manufacturers must periodically identify

and assess the occurrence and severity of adverse events, which this article undertakes to

do in relation to products containing the Echinacea extract Echinilin.

Part 1

13herbals and botanicals

herb) from the aerial parts of the plant were

examined in rats and mice for periods of

up to 4 weeks.11 Four mutagenicity assays

and one cell-transformation assay were

also performed with freeze-dried residues

(lyophilizates) of the juice. Each study

was conducted in accordance with the

internationally accepted guidelines of the

Organization for Economic Co-operation and

Development (OECD) for “Good Laboratory

Practice” and with the OECD or EC

(European Commission) recommendations

for technical methods.

In the acute studies, a single dose of

15,000 mg/kg bw E. purpurea juice was

administered by gastric tube to 8 week old

Wistar rats (eight males and eight females,

approximately 200 g each) and 8 week

old NMRI mice (eight males and eight

females; approximately 20 g each), with

each receiving 30,000 mg/kg bw in the

same manner (consuming the equivalent

of 5.1–7.5 g crude Echinacea per day).

Following administration, the animals were

observed for 14 days before termination and

necropsy. No deaths occurred during the

observation period, nor were abnormalities

in appearance or behaviour reported, and

no changes attributable to E. purpurea juice

were observed in any organ at necropsy.

The oral LD50 for E. purpurea juice was

>15,000 mg/kg bw and >30,000 mg/kg

bw in the rat and mouse, respectively. In a

parallel study by the same authors, single

doses of E. purpurea juice were administered

via IV to rats (5000 mg/kg bw) and mice

(10,000 mg/kg bw). Although minor

reactions (sedation and dyspnea) to the IV

administration procedure occurred, no other

effects were observed.

In the subacute study, E. purpurea juice

was administered via gastric tube at levels

of 0, 800, 2400 or 8000 mg/kg bw/day for

28 days to four groups of rats (18 males

and 18 females per group, consuming the

equivalent of 2.72–4 g crude Echinacea

per day). During the study body weight,

food consumption, ophthalmology, clinical

chemistry, haematology and histopathology

were evaluated for toxicological effects.

No mortalities occurred. At the end of the

study, a statistically significant decrease in

plasma alkaline phosphatase (AP) in male

rats of the 2400 and 8000 mg/kg bw/

day dose groups (P <0.01 and P <0.05,

respectively) and a statistically significant

increase in prothrombin time (PTT) in female

rats of the same groups (also P <0.01

and P <0.05, respectively) was reported.

Although statistically significant, neither the

change in AP nor the change in PTT was

considered to be toxicologically significant,

as both changes fell within the accepted

physiological variation for the strain and

neither was proportional to dose. No

significant differences in body weight or

food consumption occurred among the

groups at any time point and, in addition,

there were no reported changes from control

in ophthalmology, necropsy findings or

histopathology. The reported no-observed-

adverse-effect level (NOAEL) for fresh-

pressed E. purpurea juice was 8000 mg/kg

bw/day (equivalent to 13.6–20 g/kg bw/day

of the raw herb), which was the highest dose

administered and approximates 30 times the

maximum daily dose in humans.

In the first mutagenicity assay — the

bacterial mutation (Ames) assay — the

mutagenic potential of E. purpurea

juice lyophilizate was evaluated at

concentrations of up to 5000 μg/plate in

five test strains of Salmonella typhimurium (TA 98, TA 100, TA 1535, TA 1537

and TA 1538); no evidence of toxicity or

mutagenicity was observed, with or without

metabolic activation. Metabolic activation

was induced by using an

S-9 mixture containing

the liver homogenate

from male Wistar rats

that had been injected

intraperitoneally with 500 mg/kg

bw Aroclor 1254 and sacrificed 5

days afterwards. Similarly, in the in

vitro mouse lymphoma cell gene mutation

assay, no statistically significant increase

in mutation frequency was found in mouse

lymphoma cells treated with E. purpurea

juice lyophilizate at concentrations of up

to 5000 μg/mL, with or without metabolic

activation. The third assay, in vitro human

lymphocyte analysis, also showed no

mutagenic effect of the juice lyophilizate at

concentrations up to 5000 μg/mL with or

without metabolic activation — aberration

frequency in the human lymphocyte cells was

consistent among treatment and controls.

In the micronucleus assay, femoral bone

marrow smears from mice orally treated

with E. purpurea juice (25,000 mg/kg bw)

on one occasion and sacrificed 24, 48 or

72 hours afterwards, showed no increase in

micronucleated polychromatic erythrocytes (PCE)

compared with bone marrow smears from

control animals. To evaluate the unscheduled

DNA synthesis (UDS) potential of E. purpurea

juice lyophilizate, a cell transformation assay

January/February 2012 www.nutraceuticalmag.com

www.nutraceuticalmag.com January/February 2012

14 herbals and botanicals

with lyophilizate concentrations of up to

55μg/mL was performed; no morphological

transformations were induced in Syrian

hamster embryo cells exposed to the

lyophilizate. In each of these five supportive

assays, cells exposed to E. purpurea juice

lyophilizate and cells from animals dosed

with E. purpurea juice responded similarly

to assay negative controls and unlike the

corresponding positive controls (statistical

significance was not generally determined

for the positive control compared with the

negative control).

The results of these studies indicate that

fresh-pressed E. purpurea juice was well

tolerated in rats, with an oral NOAEL of

8000 mg/kg bw/day (equivalent to 13.6–20

g/kg bw/day of the raw herb), the highest

dose level tested. No adverse effects were

observed at dose levels approximately 30

times the maximum normal daily dose

that a human would ingest. Furthermore,

E. purpurea juice and its lyophilized residues

were demonstrated to lack mutagenic

potential and to not cause chromosomal

aberration or cell transformation.

Clinical TrialBelieved by the general population to

possess unique immunostimulatory

properties, Echinacea is included in many

dietary supplement products. Because most

Echinacea-containing preparations are not

standardized, clinical trials studying the

effectiveness of these products have often

produced inconclusive results, most likely

owing to insufficient quantities or deficiencies

in the preparation quality of Echinacea

materials. The need to evaluate a high quality

standardized preparation of Echinacea such

as Echinilin (sold in the US as Echinamide)

— for effectiveness and for incidence of

adverse reaction — thus led to a clinical

trial evaluating the effect of Echinilin on the

severity and duration of the common cold in

otherwise healthy subjects.

Similar to the E. purpurea juice

Echinacin used in the preclinical studies,

Echinilin is prepared from freshly harvested

E. purpurea. However, whereas Echinacin

is the pressed juice, Echinilin is an extract

purified to principally contain three active

components: alkamides, cichoric acid and

polysaccharides, at concentrations of 0.25,

2.5 and 25.5 mg/mL, respectively. Lacking

many of the impurities present in the raw

juice of the E. purpurea plant, Echinacin is

also somewhat more concentrated than

Echinilin; 1 mL is equivalent to 1.5–5 g of

the crude Echinacea herb whereas 1 mL

of Echinilin is equivalent to approximately

1 gram of the plant. The clinical trial,

a randomized, double-blind, placebo-

controlled study conducted at the University

of Alberta, Edmonton, Canada, showed

that Echinilin, a standardized formulation

prepared from freshly harvested E. purpurea,

administered orally for a total

of 7 days to volunteers

developing the initial

symptoms of a cold, was

well tolerated with only

mild to moderate adverse

effects, similar to those seen

with placebo.10 The primary

objective of the study was

to evaluate the effect of orally administered

Echinilin on the duration and severity of

the common cold, whereas the secondary

objective was to evaluate adverse reactions

to Echinilin in comparison to placebo.

Enrolled in the clinical trial were 282 male

and female volunteers aged 18–65 years

with a history of two or more colds in the

past year but otherwise in good health,

who were randomized to either the Echinilin

or placebo group. Exclusionary criteria

included, amongst others, recent vaccination

against influenza and allergy to ragweed. At

the onset of the first symptoms of a naturally

acquired cold, subjects were to begin the 7

day treatment programme, which consisted

of 10 doses per day on the first day and four

doses per day on the 6 subsequent days.

Each dose consisted of 4 mL of Echinilin

or placebo mixed into half a glass of water

before drinking. Subjects consumed the

equivalent of 40 g crude Echinacea on the

first day of dosing (approximately 0.67 g/kg bw)

and 16 g on each of the subsequent 6 days

(approximately 0.27 g/kg bw/day). Echinacea

and placebo extracts were prepared to look,

taste and smell the same. Of the enrolled

subjects, a total of 128 developed a cold (59

Echinilin, 69 placebo) and complied with at

least the first 2 days of the protocol by taking

14 doses of the study formulation within 48

hours of symptom onset; these subjects

were included in the ITT (intention to treat)

population. The 17 individuals from the ITT

population who failed to comply fully with

the trial criteria were excluded from the more

restrictive (most compliant) PP (per Protocol)

population. A total of 111 subjects — 54 in

the Echinilin (28 women, 26 men) and 57 in

the placebo (41 women, 16 men) groups —

developed colds and fully complied with trial

criteria; these subjects were included in both

the ITT and PP populations.

Dosing compliance was recorded daily

into a log, as was a self-assessed severity

of 13 cold symptoms (sore throat, runny

nose, stuffy nose, watery eyes, chills,

malaise, fever, headache, sore muscles,

hoarseness, shortness of breath, sneezing

and cough). Each symptom was scored

on a ten point scale as ‘no symptom’ (0

points), ‘mild’ (1–3 points), ‘moderate’ (4–6

points) or ‘severe’ (7–9 points) in nature and

a Total Daily Symptom Score (TDSS) was

generated by adding all symptom scores for

that day. Each subject that suffered from a

cold was also examined by a nurse on days

3 (after 14 doses) and 8 (after the course

of treatment), who assessed the severity of

Because most

Echinacea-

containing

preparations are not

standardized, clinical

trials studying the

effectiveness of

these products have

often produced

inconclusive results.

15strap

January/February 2012 www.nutraceuticalmag.com

Immune

100% yeast based formulation

Complex of 3 natural active ingredients:

High Bioavailable Selenium

Natural Vitamin D

Activated Yeast β-glucans

European Sales Office l +45 45 95 08 50 North American Sales Office l +1 514 381 5631

www.lallemandhi.com

EFSA 13.1 Health Claims:

“Selenium contributes to the protection ofcell constituents from oxidative damage” “Vitamin D contributes to the normal function of the immune system”

www.nutraceuticalmag.com January/February 2012

16 herbals and botanicals

cold symptoms, screened the subjects for

secondary complications such as sinusitis,

bronchitis, pneumonia and otitis media and

collected fasting blood samples for white

blood cell differential counts. Subjects were

contacted periodically during the 7 day

treatment to assess compliance, ask whether

they thought they were taking Echinilin

or placebo and request that any adverse

reaction be recorded in the log.

The parameters assessed during the

clinical trial included: the evolution of the

mean TDSS results for each day, the change

in individual symptom scores, the duration of

symptoms (indicated by the number of days

a symptom was scored above three points),

the treatment response rate (the number of

subjects reporting a decrease of at least 50%

in their maximum TDSS) and the incidence of

adverse effects.

Efficacy and Adverse EventsAs the distribution was not normal, the

data were logarithmically transformed

prior to statistical analysis. To determine

the effect of treatment and time on

TDSS and individual symptom scores,

Type III repeated-measures analysis of

variance (ANOVA) was performed. To

determine the effect of treatment on the

duration of the individual symptoms, a

one-way ANOVA was used. To evaluate

the closeness of the self-assessed and

nurse-assessed individual and total

symptom scores, Pearson correlation

coefficients were determined.10

In the PP population, statistical

analysis revealed that the average TDSS

for self-assessed cold symptom severity was

significantly lower in the Echinilin group (by

23.1%) than in the placebo group

(P <0.01). In terms of symptoms, the 7 day

mean severity of runny nose, sore throat,

stuffy nose, fatigue, headache and chills

were lower by 27%, 25%, 22%, 31%, 39%

and 44% in the Echinilin group than in the

placebo group, respectively (P <0.05 for

all). Cough was the only symptom that

scored higher in the Echinilin group than

that of the placebo. Additionally, Pearson

correlation coefficients were significantly

high, indicating that self-assessed scores

and nurse-assessed scores were extremely

similar for cough, runny nose, stuffy nose,

sore throat, fatigue and for total symptoms

(P <0.0001 for all). Blinding was demonstrated

to be adequate at the end of the study as

approximately 50% of subjects incorrectly

guessed which formulation they had

received.

The results of the ITT population were

similar, albeit less pronounced, than

those of the PP. The average TDSS for

self-assessed cold symptom severity was

significantly lower in the Echinilin group

(by 17.6%) than in the placebo group

(P <0.05). In terms of symptoms, the

mean severity of fatigue and headache

decreased significantly during the 7 days

in the Echinilin group compared with

the placebo group (P <0.05 for both).

Cough was again the only symptom

that scored higher in the Echinilin group

than in the placebo group. Owing to a

lack of compliance by 17 subjects in

the ITT population, Pearson correlation

coefficients were not determined.

In the PP population, the cold duration

in individuals in the Echinilin group was

reduced by approximately 1.5 days (27%)

compared with the placebo group, with

symptom severity dropping to 50% of

maximum by day 4 for subjects receiving

Echinilin but not until day 5.5 for placebo

subjects. On day 7, 95% of the members

of the Echinilin group exhibited symptoms

at <50% of their reported maxima; 33%

of the members of the placebo group still

exhibited symptoms at this level. Again, the

results of the ITT population were similar,

although not as pronounced; all individual

symptoms, except cough, were of shorter

duration in both populations when treated

with Echinilin than placebo. Among the ITT

population, a secondary complication in

the form of bronchitis developed in seven

participants — two individuals from the

Echinilin group and five from the placebo

group. No significant differences were

observed in the white blood cell differential

counts in either group.

Several incidents of non-severe adverse

effects were reported by both the treatment

and placebo groups of the ITT population.

Gastrointestinal effects (such as nausea,

heartburn and constipation) were reported

in 8/59 (13%) of the Echinilin subjects and

6/69 (9%) of the placebo subjects taking

at least 14 doses during a 2 day period.

Unpleasant tongue sensations (such as

itching, burning and numbness) were

reported in 8/59 (13%) of the Echinilin

subjects and in 8/69 (11%) of the placebo

subjects. No allergic events were reported

for either group during the study. Differences

between the treatment and placebo groups

were not statistically significant — results

showed that both formulations were well

tolerated and that side-effects, when they

occurred, were not sufficient to cause any

subjects to withdraw from the study.

This article will be continued in the

next issue of nutraceutical business & technology, where it will explore the

issue of postmarketing surveillance and

fully discuss the benefits, limitations and

potential applications of both the ingredient

and the means used to evaluate it.

For more informationDr Nancy J. SzaboBurdock Group801 N. Orange Ave., Ste. 710 Orlando, Florida 32828, USA.Tel. +1 4078 021 400nszabo@burdockgroup.com

In the PP population,

statistical analysis

revealed that the

average TDSS for

self-assessed cold

symptom severity was

significantly lower

in the Echinilin

group ... than in the

placebo group

Superba™ Krill Oil is an excellent pure source of marine omega-3 fatty acids. The omega-3’s EPA & DHA from krill are present in the highly bio-efficient phospholipid form, which provides unique health benefits. Superba™ Krill Oil is also extremely tolerable and free of repeat-ing or “fishy burps”.

Omega-3 Phospholipid EPA & DHA are important build-ing blocks for healthy cell membranes. The ratio of EPA & DHA to other fatty acids in the membrane is called

www.superbakrill.com superba@akerbiomarine.comPhone: +47 24 13 00 00 The superior omega-3

100% Krill Oil

Small Size

No Aftertaste

No Burps

Traceability

More Bio-Efficient

Greater Stability

Healthy Skin

Healthy Heart

Healthy Joints

Healthy Brain

Eco-Friendly

From the Purest Waters on Earth

So much.So little.Superba™ Krill Phospholipid EPA/DHA Omega-3s

the Omega-3 Index – a strong indicator of cardiovas-cular health. In a recent human study, Superba™ Krill Phospholipid EPA & DHA had a significantly improved Omega-3 index compared to ordinary fish oil.

AkerBioMarine is the only krill harvester that has been awarded the prestigious Marine Stewardship Council certification for its eco-friendly harvesting and trace-ability from sea to shelf.

Visit our stand # 3 E 5 3 at FI Europe

SUPERBA_AD_A4_NBT_OCT2011.indd 1 18.10.11 10.17

www.nutraceuticalmag.com January/February 2012

18 essential fatty acids

One novel source of phospholipid

omega-3 PUFAs is krill oil extracted

from Euphausia superba, an

Antarctic krill species. Krill has a

shrimp-like appearance with big black eyes and

a reddish, semi-transparent shell. They live in

huge swarms in the cold Antarctic waters of the

Southern Ocean, feeding on microscopic marine

algae rich in enzymes that can produce omega-3

fatty acids, which are then accumulated in the krill

themselves and can subsequently be extracted

in krill oil. Moreover, algae are capable of

synthesizing the powerful antioxidant astaxanthin,

which is taken up by krill and protects PUFAs

from oxidation — it is also the reason for the

characteristic deep red colour of krill oil.

Most importantly, the majority of the EPA

and DHA in krill oil is bound to a particular type

of fat — phospholipids — unlike other marine

oils, which confine them to different chemical

forms of fat, usually either triglycerides or ethyl

esters. The differences are quite significant,

particularly in the area of utilization by the

body: dietary triglycerides and phospholipids

differ in their physiological functions in the

body; triglycerides are primarily used either

as energy or as energy storage in fat tissues.

When delivered in triglyceride form, a portion of

the beneficial omega-3s are burned as energy

or stored in the body’s fat reserves — as a

result the dosage of triglyceride omega-3 oils

must be large enough to compensate for that

loss and ensure that sufficient omega-3s are

available on a cellular level.

Recent human clinical studies have shown

that phospholipid omega-3s may be a

more desirable form. When compared with

triglyceride omega-3s, a smaller amount of

the phospholipid kind is required to achieve

equal bioavailability in the body’s cells and

organs, which results in krill oil capsules being

smaller than their fish oil counterparts. There’s

more good news that consumers will love:

krill oil is dispersible in the stomach fluids,

eradicating the repeating that fish oil capsules

so commonly incur.

Studies have demonstrated that increased

blood levels of EPA and DHA are accompanied

by health benefits in humans, placing great

importance on the bioavailability of these

omega-3 fatty acids in the blood. The term

‘bioavailability’ refers to how much of a

substance reaches the blood and describes

absorption and survival rate of said substance

in the body. Two recent human intervention

studies investigated whether the molecular form

(phospholipid versus triglyceride) of omega-3

fatty acids is important for the bioavailability

of EPA and DHA in blood plasma. The study,

performed by Kevin C. Maki and his co-workers

at the Provident Clinical Research and Meridien

Research Centres, USA, was conducted as

a randomized, double-blind, parallel arm trial.

Within this setup, 76 overweight and obese

men and women were randomly distributed into

three groups to take Superba Krill oil, fish oil, or

olive oil for 4 weeks. To avoid any influence, the

supplementation given was unknown to both

the study subjects and researchers. Whereas

the received daily amount of EPA was similar

in the krill and fish oil groups, the DHA quantity

was approximately half as much in the krill oil

group as that in the fish oil group. Nevertheless,

at the end of the study period, plasma analysis

showed that the mean EPA concentrations

were higher in the krill oil than the fish oil group

and the mean DHA concentrations were similar

in both groups. Both sources of omega-3 fatty

acids were safe, generally well-tolerated and

significantly increased EPA and DHA levels in

plasma compared with the control group. Most

importantly krill oil supplementation (2 g/day)

resulted in increased plasma EPA bioavailability

and, in the case of DHA, equal bioavailability but

at half the dosage of fish oil. Overall, after dose

adjustment, the total increase of EPA and DHA

in the plasma of subjects who received Superba

Krill oil for 4 weeks was 24% higher than that of

the subjects who received fish oil (Figure 1).

The second study, performed by researchers

at Akershus University College and University

of Oslo, investigated whether a lower dose

of EPA and DHA provided in phospholipids,

compared with omega-3 fatty acids provided

in triglycerides, shows equal bioavailability of

these fatty acids in plasma. In this study, 113

subjects with normal or slightly increased total

blood cholesterol and/or triglyceride levels

were randomized into three groups and given

THE ALPHA TO OmEGA OF krILLDietary intake of the long-chain omega-3 polyunsaturated fatty acids, EPA and DHA, has been associated with many health benefits — from cardiovascular health and improved cognitive function to reduced levels of inflammation. Although various organizations have established recommended daily intakes for EPA and DHA, the typical western diet is known to fall short of these, requiring dietary supplementation to make up the shortfall.

Figure 1: The plasma increase (%) in total EPA and DHA after either 4 or 7 weeks of Superba Krill oil, in comparison with fish oil supplementation (values have been dose adjusted).

January/February 2012 www.nutraceuticalmag.com

19essential fatty acids

Superba Krill oil, fish oil or placebo for 7 weeks.

The daily supplementation of total EPA and

DHA was approximately 37% less in the krill

oil group than in the fish oil group. Results

showed that dietary omega-3 administration

led to a similar increase of plasma omega-3

fatty acids in both the krill and fish oil groups

compared with the control group. These

findings suggest that a lower dosage of EPA

and DHA in phospholipid form is required to

obtain comparable plasma EPA and DHA

levels to the triglyceride form of omega-3

supplementation. After adjustment of EPA

and DHA levels to the daily dose given, the

results from the krill oil group suggest a total

EPA and DHA plasma level that was 45%

higher than in the fish oil group after 7 weeks of

administration. Moreover, the subjects with the

highest baseline values of triglycerides further

benefited from krill oil supplementation and

showed decreased plasma triglyceride levels.

Additionally, the HDL-cholesterol/triglyceride

ratio, a risk predictor for heart disease, was

significantly decreased after Superba Krill oil,

but not fish oil, treatment.

These two human clinical studies

demonstrate that intake of Superba Krill oil

is more potent than fish oil in increasing total

plasma EPA and DHA values and suggest

that there is a higher bioavailability of omega-3

fatty acids bound to phospholipids than in the

triglyceride bound omega-3s found in fish oil.

In the first study mentioned, in which 2 g

of Superba Krill oil was administered for 4

weeks, the blood levels of endocannabinoids

were also measured. The results confirmed

data in the literature describing increased

levels of endocannabinoids in overweight

and obese persons with respect to normal-

weight subjects. Superba Krill oil — but

not menhaden oil or olive oil — was able to

significantly decrease 2-AG in obese subjects,

which correlated with a decreased plasma

phospholipid omega-6/omega-3 ratio. These

data show for the first time that relatively

low doses of omega-3 fatty acids such as

Superba Krill oil can significantly decrease

plasma 2-AG levels in obese human subjects

and reveal that it presents a promising

approach for counteracting elevated EC

levels. By changing the balance between

omega-6 and omega-3 fatty acids and

reducing EC precursor availabilities, Superba

Krill oil may provide therapeutic benefits

such as lowered triglyceride blood levels

and decreased fat deposition in and around

organs. It could also alleviate metabolic

dysfunctions such as dyslipidemia, visceral

adiposity and the associated inflammatory

states that play a role in atherogenesis and

the subsequent increased cardiovascular risk.

Krill are an underexploited biomass —

one that is more than double the size of

that of all humans. Aker BioMarine has

made a commitment to sustainability

and maintaining the highest standards in

all aspects of the krill fishing operations.

The company conforms to all CCAMLR

requirements and has taken sustainability

and environmental responsibility even further

by addressing all the issues on CCAMLR’s

wish list of best practices, co-operating

with WWF-Norway in conservation efforts

and obtaining MSC certification for the

sustainability and full traceability of Aker

BioMarine’s krill products, from sea to

shelf. Although krill’s health benefits have

been explored in several studies, many of

the potential areas of its health-promoting

effects are as yet unknown. In addition,

various interesting data have been obtained

in preclinical studies that are yet to be

confirmed in human trials; of particular

interest will be the areas of joints, brain

health and pet food. Krill oil supplements

provide an excellent source of EPA and DHA

— phospholipid omega-3s — and, owing

to its increased bioefficiency, improved

compliance and eminent sustainability, is

arguably superior to others available.

For more informationHenrik TraaholtBusiness Director and Brand Manager, EuropeAker BioMarineTel. +44 241 300 00henrik.traaholt@akerbiomarine.comwww.akerbiomarine.com

www.nutraceuticalmag.com January/February 2012

essential fatty acids

NBT: Can you comment on Neptune’s recently issued US patent novel for omega-3 fatty acid phospholipid compositions suitable for human consumption and what message that sends to the EFA market?WM: We are extremely proud of achieving both

recently issued patents — ‘348 and ‘825 — both

of which reaffirm Neptune’s position as pioneer

and leader of the krill oil industry. The ‘348 patent

provides Neptune with the right to exclude others

from making, using, selling, offering for sale or

importing the patented invention for the term of the

patent, which is valid and has full force and effect

regardless of any re-examination request made by

a third party. The USPTO, the foremost reputable

authority for awarding patents to their entitled

inventors, concluded that the claims are novel and

non-obvious — and thus patentable. We hope

this sends the message that we are open for

business and willing to discuss mutually beneficial

agreements with all distributors interested in

capitalizing on this rapidly growing krill oil market.

NBT: In a similar vein, one of your customers was recently awarded “Product of the Year 2011” in Denmark, which suggests positive consumer uptake. What factors do you think led to that success and how can you improve end-user market penetration?WM: Although Neptune as a manufacturer

does not directly market to end-users, we do

offer technical, scientific and marketing support

for those who require such assistance in their

consumer approach. This is the second time in

a year that NKO has been recognized as a best

product, an achievement of which we are very

proud. Consumers are aware that Neptune’s

krill oils offer them the best quality krill oil that is

supported by clinically proven health benefits.

NBT: Critics have recently questioned the sustainability of krill fishing in the Southern Oceans. How would you respond to these comments?WM: To overcome this highly sensitive issue,

Neptune only sources krill through CCAMLR

licensed vessels. The Commission for the

Conservation of Antarctic Marine Living

Resources (CCAMLR) is the only official and

reliable international organization involved

in Antarctic krill fishery management and is

unique in involving the governments of 25 state

member nations — in addition to concerned

stewardship organizations such as the Antarctic

and Southern Ocean Coalition (ASOC), which

counts Greenpeace as a member. CCAMLR

establishes detailed precautionary measures to

ensure and confirm the ecological sustainability

of harvesting the Antarctic krill species

(Euphausia superba) and has never forecasted

a shortage of it. In 2009/10, 11 vessels, all

of which acted within CCAMLR guidelines,

were licensed to fish krill in the Antarctic. The

total precautionary catch limit of 2009/2010

corresponded to 1.56 % of the total biomass

figure of 420 million tonnes and the total catch of

all CCAMLR certified vessels for 2009/2010 was

only 5.54% of the established quota. Neptune

only captured 0.006% of the total biomass and

0.04% of total precautionary catch limit.

NBT: Neptune’s chief scientific officer was recently quoted as stating that the patent (US No. 8,030,348) also “benefits our majority-owned subsidiaries, Acasti Pharma and NeuroBioPharm, as it protects the platform for our pharmaceutical products.” Is the convergence of the two sectors important to Neptune, and how do you see your nutra/pharma activities aligning in the future? WM: Our nutra and pharma activities will

always be aligned in the sense that Neptune

will be the exclusive supplier of raw material

to both its pharmaceutical subsidiaries (Acasti

Pharma and NeuroBioPharm), which will always

have the exclusive world license for Neptune’s

patents in their respective sectors. On one

hand, Acasti Pharma, Inc. is dedicated to the

research, development and commercialization

of its proprietary product portfolio for the

management of cardiometabolic disorders —

from prevention to treatment. Acasti develops

first-in-class and best-in-class anti-dyslipidemic

prescription drugs (Rx), medical foods (MF)

and over-the-counter (OTC) products. Acasti’s

lead product, CaPre, intended for use in the

treatment of dyslipidemia, has demonstrated a

superior efficacy and safety profile in established

preclinical models. NeuroBioPharm, by contrast,

is dedicated in the research, development and

commercialization of its proprietary product

portfolio for the management of neurological

disorders, also from prevention to treatment. By

targeting the cardiovascular and neurological

sectors, Neptune and its subsidiaries have the

potential to play a major role in the management

of the world’s most prevalent human diseases

and disorders.

NBT: Perhaps driven by the convergence of the pharma/nutra industries, you’ve undertaken a large dietary supplement clinical study: what results do you hope to achieve and should this be a model for the whole functional food industry?WM: Neptune has undertaken several clinical

studies to meet the demands of the changing

market. Regulatory requirements in Europe,

Asia and even the US are becoming stricter

and more demanding in terms of the criteria

required to obtain and use health claims. With

all these clinical studies we are confident of

achieving significant results that will provide us

with the necessary tools to submit and obtain

approved health claims. The design of clinical

studies is more critical than ever before and we

have accumulated much knowledge of what

each international regulatory body requires for

approving health claim submissions.

NBT: Finally, like Big Pharma, the nutraceutical industry is becoming more litigious: can we expect to see more IP/patent disputes or are there steps that can be put in place to avoid such issues?WM: Is Nutra Industry really becoming more

litigious? I see the industry becoming a little

more structured now that the FDA has decided

to play a bigger role in enforcing regulation.

However, from an IP point of view, I think

there will always be companies that decide

to operate regardless of the IP in the market

they are targeting. Unfortunately this leads to

unnecessary lawsuits for the IP holders who

simply wish to protect what has been rightfully

granted to them by the USPTO.

PrOTECTING THE PLATFOrmFollowing its recent issue of a of a US patent, nutraceutical business & technology spoke with Dr Wael Massrieh, VP of scientific affairs at Neptune Biotechnology, to discuss the protection of their innovative platform … and of the raw material itself.

For more informationDr Wael Massrieh VP of Scientific Affairsw.massrieh@neptunebiotech.comwww.neptunebiotech.com

20

January/February 2012 www.nutraceuticalmag.com

www.nutraceuticalmag.com January/February 2012

22essential fatty acids

Table I: Alpha-linolenic acid content in plant-derived oils.

TAkING THE FLAxA focus on healthier lifestyles has led to a surge in the popularity of foods enriched with essential fatty acids (EFAs) — such as omega-3s — which offer a variety of health benefits, including those associated with cardiovascular health. These benefits are increasingly being delivered through the use of ingredients that contain high levels of omega-3s. With their growing market potential and consumer preference, omega-3s are expected to continue to penetrate the functional foods and dietary supplements arena in coming years.1

The wealth of clinical research on

omega-3s has rapidly translated into

rising consumer recognition of their

health benefits.2 As such, the global

omega-3 ingredients market is estimated

to reach $3.21 billion in 2016, compared with

$1.48 billion in 2010. Europe’s current socio-

demographical trend of eating foods with known

physiological benefits and taking precautionary

health measures makes it the fastest growing

segment — the omega-3 market in this region

alone is set to rise from $311.2 million in 2010

to $771.8 million in 2016. This increased

market penetration can be attributed largely to

technological advancements that have widened its

available sources and enabled its incorporation into

a broader range of food and beverage applications.

Essential SourcesOmega-3 fatty acids are derived from two

main dietary sources: seafood and certain nut

and plant oils. Marine-derived omega-3 fatty

acids, namely eicosapentaenoic acid (EPA)

and docosahexaenoic acid (DHA), are found in

particularly high concentrations in deep water

oily fish, such as anchovies and sardines. These

EFAs, which play an important role in human

health and are a vital component of a healthy

diet, have recently attracted the media spotlight,

resulting in broad consumer recognition of the

benefits of oily fish. Another source of omega-3

EFAs that is growing in popularity is flaxseed: it

was flaxseed and other foods rich in alpha-linolenic

acid (ALA) that earned a reputation for healthy

living in the past — and this recognition is being

reawakened. Flaxseed provides the richest

vegetarian source of ALA available, containing

more than five times the ALA content of most

other common plant oils (Table I).

The ‘True’ Essential Fatty AcidALA is the only essential omega-3 fatty acid

that is actually required in the diet, as it cannot

be synthesized by the body but is critical to

human health — particularly for normal growth,

development, reproduction and vision. Previous

attempts at parenteral nutrition without EFA

content has led to individuals exhibiting negative

physiological symptoms including eczema,

neuropathy or an impaired immune system.3

One aspect that is yet to be recognized or

fully comprehended by consumers is that ALA

can be converted into EPA and DHA through

metabolic pathways. Several studies have

attempted to identify the conversion rate of ALA

into EPA and DHA but the results have varied

widely. A recent study provided evidence for the

in vivo conversion of ALA into EPA and DHA and

may help to explain variations that have occurred

in previous studies.4 This cohort study helped

to answer a burning question within the food

technology community: whether plasma levels of

EPA and DHA depend solely on dietary intake,

or if ALA omega-3 sources provide an adequate

dietary substitute via in vivo conversion to EPA

and DHA.

The study analysed the dietary consumption

of 14,422 men and women (aged 39–78),

subdivided into four groups (fish eaters, non-fish

eating meat eaters, vegetarians and vegans).

Circulating levels of omega-3 fatty acids were

measured in a subgroup of 4902 individuals,

the results were compared with dietary habits

and inferences were made regarding conversion

rates of ALA to EPA and DHA. The results of

the study showed that circulating levels of DHA

and EPA were very similar in the fish eaters and

non-fish eaters. The authors concluded that the

conversion rate of ALA to EPA and DHA was

significantly higher in those who did not consume

fish; in other words, not consuming fish appears

to increase the rate of conversion of ALA to EPA

and DHA. This could mean that ALA is a key

component in the modulation of circulating levels

of ALA, EPA and DHA.

As described above, the key observation is

that the consumption of fish provides significant

dietary sources of EPA and DHA. Despite this,

however, circulating levels of EPA and DHA are

very similar among the various cohort groups,

Plant Oil ALA Content

Flaxseed oil 50.8%

Soy oil 7%

Canola oil 9.3%

Corn oil 1%

Olive oil .06%

January/February 2012 www.nutraceuticalmag.com

including those that did not consume fish.

Furthermore, this similarity between circulating

levels of the fatty acids of fish eaters and non-

fish eaters, despite the large difference in dietary

consumption, suggests an important role for

ALA as a precursor for in vivo synthesis of the

fatty acids. This emphasizes the importance of

ALA as a truly essential fatty acid.

The Heart of the MatterALA performs some of the same functions as

other omega-3 fatty acids such as EPA and

DHA long-chain fatty acids, which is logical

considering the in vivo conversion of ALA into

EPA and DHA — for example, research shows

that ALA helps to protect against cardiovascular

disease.5 Diets rich in ALA lower the risk of

coronary heart disease (CHD), ischemic heart

disease, nonfatal myocardial infarction and

stroke; in fact, a meta-analysis of prospective

studies suggested that increasing the intake of

ALA by 1.2 g/day decreases the risk of fatal CHD

by at least 20%.6

Additionally, ALA is linked with helping to

decrease body inflammation, which is a key

feature of many chronic conditions such as

coronary heart disease, stroke and cancer.7

ALA-rich diets reduce the concentrations

of pro-inflammatory compounds such as

cytokines, along with indicators of whole-body

inflammation, for example C-reactive protein,

by as much as 18–75%.8,9,10 ALA also helps to

reduce arrhythmia (infrequent heart beats).11

Flax-ing LyricalThe European guideline daily allowance (GDA) for

ALA intake is 2 g/day.12 As a result of these GDA

guidelines, consumers are looking for new ways to

add omega-3 to their diets; products formulated

with flax are rich in omega-3 ALA and offer the

benefits of a clean label. When comparing the

supplements market with functional foods and

beverage applications, the main difference in

omega-3 ingredients is the form of the products

used. Milled flaxseed omega-3 is traditionally

used in functional foods and beverages, taking

advantage of the many health promoting

properties of flaxseed, including antioxidants,

lignans and fibre. Supplement manufacturers, in

contrast, tend to prefer omega-3 in its oil form for

obtaining the purest form of omega-3 possible

and positioning their supplements with a clear,

simple label and direct messaging.

A range of flax ingredients is now available

to help manufacturers to provide nutritious

solutions for their formulations. Some flax-

based products offer all three forms of omega-3

in a dry powder format, which benefit from a

naturally long shelf-life of 12 months without the

need for refrigeration or special handling. The

benefits of these flax ingredients reach beyond

enhanced nutritional value; for example, their

inherent functional components such as fibre

allow them to be used as formulation enhancers

or to improve moisture in breads, replace fats,

provide allergen-free options and enhance

shelf-life and texture.

Banish Formulation ChallengesThe ‘nutty’ and ‘toasted’ sensory profile of

high performance flaxseed-derived omega-3

ingredients provides manufacturers with a great

tasting way of adding wholegrain-style healthy

functionality to baked goods, cereals and bars,

in addition to dough applications such as pizza

and tortillas. Critically, flax does not adversely

affect the taste of many foods and is particularly

suited to, for example, fortifying baked goods. In

addition, the omega-3-rich oil in flaxseed is more

stable than in fish oil and less prone to oxidation,

offering manufacturers a stable approach to

omega-3 fortification.

A unique property of flaxseed is that it contains

a gum matrix, known as ‘gum mucilage.’ OptiSol

5000 functional flaxseed products have now

been developed using a proprietary milling and

processing system; a range of ingredient solutions

that can be used to replace hydrocolloid systems

in food applications, including gluten-free baked

goods, where they can improve both texture

and shelf-life in tortillas, sheeted doughs, batters,

breadings, sweet baked goods and fresh breads.

Furthermore, the flax-based omega-3 ingredients

can be easily incorporated into a wider variety

of foods including beverages, pasta, cereals,

dressings and sauces — as well as certain

processed meat applications. Another benefit is

its clean-label advantage; it can be listed simply

as “flaxseed,” while contributing to omega-3

and fibre health claims. A patented cleaning and

stabilization process known as MeadowPure

guarantees a highly stable end product, with a

shelf life of up to 2 years.

ConclusionThe proven health benefits of ALA omega-3

— and the corresponding consumer interest

— has led to the further development of high

performance flax-derived omega-3 functional

ingredients. As with most food and beverage

products, consumers want to improve their

health in the way that is most convenient for their

lifestyle. As such, flaxseed-derived ALA omega-3s

provide the dual benefits of a high ALA content

and an excellent sensory and functional profile.

In this way, manufacturers benefit from the ease

of formulating omega-3 into their products, while

consumers can gain significant health benefits.

23essential fatty acids

For more informationEric BochardtDirector of MarketingGlanbia NutritionalsTel. +1 608 316 8521www.glanbianutritionals.com

References1. Market to Market, “Omega-3 & 6 Market by Source,

Geography Trends & Global Forecasts,” August 2011 (http://www.marketsandmarkets.com/ Market-Reports/omega-3-omega-6-227.html).

2. Frost & Sullivan, “Consumers Becoming Increasingly Savvy About Marine and Algae Oil Omega-3 Ingredients,” 20 July 2010 (http://www.frost.com/prod/servlet/press-release.pag?docid=207388177).

3. R.T. Holman, “The Slow Discovery of the Importance of Omega 3 Essential Fatty Acids in Human Health,” J. Nutr. 128(2), 427–433S (1998).

4. A.A. Welsh, et al., “Dietary Intake and Status of n-3 Polyunsaturated Fatty Acids in a Population of Fish-Eating and Non-Fish-Eating Meat-Eaters, Vegetarians and Vegans and the Precursor-Product Ratio of {alpha}-Linolenic Acid to Long-Chain n-3 Polyunsaturated Fatty Acids: Results from the EPIC-Norfolk Cohort,” Am. J. Clin. Nutr. 93(3), 676 (2010).

5. C.R. Harper, et al., “Flaxseed Oil Increases the Plasma Concentrations of Cardioprotective (n-3) Fatty Acids in Humans,” J. Nutr. 136, 83–87 (2006).

6. I.A. Brouwer, et al., “Dietary α-Linolenic Acid is Associated with Reduced Risk of Fatal Coronary Heart Disease, but Increased Prostate Cancer Risk: a Meta-Analysis,” J. Nutr. 134, 919–922 (2004).

7. G. Zhao, et al., “Dietary α-Linolenic Acid Inhibits Proinflammatory Cytokine Production by Peripheral Blood Mononuclear Cells in Hypercholesterolemic Subjects,” Am. J. Clin. Nutr. 85, 385–391 (2007).

8. G. Barcelo-Coblijin, et al., “ALA and its Conversion to Longer Chain n-3 Fatty Acids: Benefits for Human Health and a Role in Maintaining Tissue n-3 Fatty Acid Levels,” Prog. Lipid Res. 48(6), 355 (2009).

9. G. Zhao, et al., “Dietary Alpha-Linolenic Acid Reduces Inflammatory and Lipid Cardiovascular Risk Factors in Hypercholesterolemic Men and Women,” J. Nutr. 134, 2991–2997 (2004).

10. G. Zhao, et al., “Dietary α-Linolenic Acid Inhibits Proinflammatory Cytokine Production by Peripheral Blood Mononuclear Cells in Hypercholesterolemic Subjects,” Am. J. Clin. Nutr. 85, 385–391 (2007).

11. B.C. Davis, et al., “Achieving Optimal Essential Fatty Acid Status in Vegetarians: Current Knowledge and Practical Implications,” Am. J. Clin. Nutr. 78, 640S–660S (2003).

12. Guideline Daily Amounts: http://gda.ciaa.eu/asp2/gdas_portions_rationale.asp?doc_id=129.

www.nutraceuticalmag.com January/February 2012

24natural sweeteners

A swEET EsCAPESweetness, one of the five basic tastes, is generally accepted as being pleasurable. For many years sugar (sucrose) and honey (fructose and glucose) were its main sources but, more recently, there has been an increase in both the number and use of alternative, high potency sweeteners that work to lower the calorie content of foods and beverages. This capacity is given particular relevance by the increasing importance of issues surrounding calorie intake and weight management to customers; according to Tate & Lyle studies, 60% of European adults say that they limit high sugar content and calories within their diet.

sugar reduced products offer a way for

consumers to moderate their calorie

intake: replacing all or some of a product’s

sugars with high potency sweeteners is an

effective and cost-efficient approach to reducing its

sugar content. One of the more recent high-potency

sweeteners to be approved for use in Europe is

sucralose, which was developed by Tate & Lyle,

following an intensive research programme.

SPLENDA Sucralose is a zero calorie sweetener

that is made from cane sugar — but is not sugar. Its

sweetening power is approximately 600 times that

of sugar and its sugar-like taste gives it the benefit of

helping to moderate calorie intake while providing an

intensely sweet taste. It is suitable for use in a diverse

range of products including carbonated beverages,

ice cream, dairy desserts, salad dressing, hard boiled

candies and many more. Now, with more than 5000

of the world’s leading consumer products relying on

its great-tasting, zero-calorie sweetness, SPLENDA

Sucralose has set the bar for being the consumers’

sweetener of choice.

Unmatched Taste Taste is vital to any food or beverage product and, to

be successful, sugar-reduced offerings must be as

appealing to consumers as their full-sugar alternatives.

Consumers refuse to compromise on taste, with most

only repeatedly purchasing reduced-sugar alternatives

when they are convinced of the high sensory profile of

the product. Thanks to its sugar-like sweetness and

flavour profile, SPLENDA Sucralose offers a solution for

replacing the sweetness provided by sugar in virtually

all food products, while maintaining the great taste and

premium image.

Its sweetness profile is very similar to that of sugar,

as demonstrated in time intensity measurements. At

5% sugar equivalence, typical of sweetened tea and

coffee, SPLENDA Sucralose displays a rapid onset of

sweetness and similar sweetness duration to sugar.

In addition to their sweetness, sweeteners possess

a number of other tastes that contribute to an overall

flavour. The flavour profiles of SPLENDA Sucralose

and sugar are very similar. To compare them, a 12

member taste panel evaluated equally sweet solutions

of SPLENDA Sucralose and sugar, equivalent to 9%

sugar and prepared in water with a neutral pH. The key

taste attributes were assigned a score rating by each

individual member, which were then averaged and

found to demonstrate the similarities between the two

flavour profiles.

Unbeatable StabilityIn addition to assisting consumers to moderate their

calorie intake with great tasting products, SPLENDA

Sucralose also has a number of other qualities that

make it appealing to food and drink manufacturers;

for example its technical advantage of stability during

processing and long-term storage, even when

incorporated in low pH products. SPLENDA Sucralose

January/February 2012 www.nutraceuticalmag.com

25strap

www.nutraceuticalmag.com January/February 2012

26natural sweeteners

For more information Rony Van Den AbbeeleProduct Manager, Sucralose, Tate & Lyle Speciality Food IngredientsRony.vandenabbeele@tateandlyle.comwww.tateandlyle.com

is extremely heat stable, even when exposed

to high temperature food processing such as

pasteurization, sterilization, UHT and baking.

This stability during food manufacture has

been confirmed by a series of processing trials,

which cover the main processes used in the

food industry; regardless of the application

investigated — from a low pH pasteurized

juice drink to a UHT yoghurt — the analysis of

samples confirmed that no measurable loss of

the ingredient had occurred during processing.

The product also maintains its sweetness

and flavour during storage, avoiding the

development of off-flavours, even at a low

pH; shelf-life studies have demonstrated

that products sweetened with SPLENDA

Sucralose retain their sweetness throughout

extended periods of storage and independent

investigations have also shown that the flavour

characteristics of products in which it is the

predominant sweetener will age in a similar

manner to a full sugar product. Its excellent

stability means that the sweetness profile is

maintained throughout its shelf-life and the

true flavour of the product is delivered more

consistently, irrespective of the challenging

conditions in some distribution channels.

Sweet Combinations for Increased CompetitivenessIn addition to the consumer desire for

products with less sugar and fewer calories,

cost is a further factor that determines

demand — sugar prices are expected to

remain volatile for the foreseeable future,

making costs more difficult to manage and

profitability more challenging to maintain.

Replacing sugar with SPLENDA Sucralose

provides an effective method of combining

a reduction in costs with meeting consumer

demand for products with fewer calories.

The regulatory cut off point for making

‘sugar reduced’ claims is 30%, which has

traditionally led companies to aim to reduce

calories by 30%. SPLENDA Sucralose has

been successfully used alone, reducing

sugar levels by 30% and achieving significant

cost savings on sweeteners. However,

when reducing sugars to meet economic

objectives, a light positioning is not inevitable;

reformulated products can also be intended to

sit on the shelf beside the full calorie versions.

Although in the interests of cost reduction

it makes sense to extend sugar reduction

beyond this 30% cut off, this creates a

formulation challenge, as products must retain

their original taste.

To this end, Tate & Lyle has developed

innovative new concepts to help its customers

to get ahead of the competition. For example,

it recently developed an orange carbonated

soft drink that delivers a sugar reduction of

50% compared with the full sugar version

and a significant sweetener cost saving of

up to 40%, while still providing the great

taste, sweetness and mouthfeel consumers

look for. The combination of fructose and

SPLENDA, which have complementary

sweetness profiles, used in this case provides

a sweetness synergy that allows a greater

sweetener and calorie reduction. Fructose has

a faster onset of sweetness perception, which

boosts fruity tones and spice flavours and

helps to deliver a more balanced sweetness

and taste profile (Figure 1).

This combination gives manufacturers

the opportunity to replace traditional full-

sugar drinks with a lower cost alternative

that has fewer calories. Sucralose works

well in combination with many other nutritive

sweeteners; it has been shown that blending

it with nutritive carbohydrate sweeteners

creates an excellent sweetness quality

and, in most cases, a degree of sweetness

synergy that results in incremental cost

savings. Studies have demonstrated that

partial replacement of the nutritive sweetener

with SPLENDA Sucralose can be achieved

without detrimentally impacting the flavour

or sweetness in various food and beverage

systems. Furthermore, the combination is

sometimes sweeter than the sum of the

individual sweeteners — as is the case when

formulated with fructose. The ingredient can

also be used in combination with any other

high potency sweeteners; an experienced

product developer will be able to customize

the sweetness and flavour profile of the

sweetening system to meet particular taste

or budget requirements by blending high

potency sweeteners; SPLENDA Sucralose

will exhibit its cost saving advantages when

combined with most of these.

Tate & Lyle has gained more than 30

years of experience working with sucralose

and has pioneered the development of

the most sophisticated manufacturing and

testing processes used today. The company

states that it is committed to delivering a

consistent, reliable supply of the sweetener

— manufactured to the highest standards of

purity and hygiene.

Figure 1: Comparative onsets of sweetness perception of fructose and sucralose.

January/February 2012 www.nutraceuticalmag.com

www.nutraceuticalmag.com January/February 2012

28natural sweeteners

wELCOmING A NEw ErAThe 11th of November 2011 was a very special day … and this was not only because it could be written 11.11.11! It was also the publication date of the EU Regulation marking the formal opening of the whole European market to stevia-based sweeteners.

stevia is currently successfully used as a

sweetener in Asia, North America and

South America and products made from

it have been on the French market for

2 years, under temporary approval. Only now,

however, are food and drink manufacturers able

to take an EU-wide perspective on developing

new food and beverage formulations that include

naturally-sourced, calorie-free sweetness.

Popular interest exists, but expectations are high;

consumers are watching their calorie intake more

carefully, but still resist compromising on taste

and eating experience in the products they buy.

Furthermore, they increasingly prefer ingredients

and products to be as natural as possible and

demonstrate high ethical standards on the part of

the companies behind them.

This presents a huge opportunity — and a

significant challenge — to manufacturers. First,

there’s the question of working out how to

formulate successfully. Second, the vital issue

of how to position stevia-based products and

finally, how best to ensure consistent ingredient

quality and availability to support roll-out

on a pan-European scale. Cargill has been

addressing these questions since 2004, when

the decision was made to build a brand new

Truvia business standing for quality, consistency

and sustainability in stevia. Since then it has

conducted almost 60,000 hours of food and

applications work to bring Truvia stevia leaf

extract to market, establishing three crucial

success factors in the process.

CapabilityStevia is not a ‘single ingredient’ solution. To

reduce calories without reducing taste and

enjoyment, you can’t simply replace sugar

with Truvia stevia leaf extract. The whole food

matrix needs to be rebalanced to suit precise

requirements. Cargill is in a strong position to

undertake this reformulation effectively with its

range of sweeteners, texturizing ingredients

and other ingredients such as cocoa and

chocolate. This interconnected in-house

capability has driven the creation of Truvia

stevia leaf extract and is now inspiring the

creation of successful products.

Working with more than 100 food and

beverage companies, Cargill has helped to

launch great tasting stevia-sweetened products

across four continents. In the US, Truvia stevia

leaf extract is present in Glaceau Vitaminwater

zero and Powerade beverages and YoCrunch

yoghurt, among many other products. In France,

the extract is used in Coca-Cola’s Fanta Still and

Eckes-Granini’s Joker and Réa brands.

29natural sweeteners

ww

w.s

tolz

-con

cept

.de

We’re taking a (super)critical look at extract quality

FLAVEX® Naturextrakte GmbH · info@flavex.com · www.flavex.com

A5 quer-4c-D-F-E:Layout 1 07.09.2010 15:23 Uhr Seite 3

Brand ActivationOn pack branding can make consumers

aware of reformulated products and

promote trust in an ingredient — but how is

awareness of an ingredient brand generated?

Cargill’s Truvia brand tabletop sweetener,

containing Truvia stevia leaf extract has been

extremely successful in the US, becoming

the number one natural sweetener brand and

recognized by 57% of consumers. Following

partnership agreements signed with leading

sugar brands Silver Spoon in the UK,

CristalCo (Daddy) in France, Eridania in Italy

and Azucarera Ebro in Spain, the sweetener

is being launched in Europe as from now,

with a £5 million consumer advertising spend

in the UK alone. Truvia branding works: in

the US, a leading powdered beverage brand

has moved from being a reluctant user of the

brand to whole-hearted endorsement after

capturing the benefits of the Truvia consumer

campaigns and awareness building.

SustainabilityCargill has drawn substantial experience

of agricultural supply chains in mature

and developing agricultural businesses

from its 146 year history and the supply

chain for Truvia stevia leaf extract has

been in development for the past 7 years.

The company manages every step of

the production process, incorporating

strong environmental, economic and

social standards and working to the vision

of a sustainable product that supports

growers. Comprehensive standards,

targets and processes, such as working

with the Carbon Trust towards a goal of

becoming carbon neutral in 2020, have

been developed and, as part of its desire

to be measurable in this area, Cargill

has invited inspection and scrutiny of its

processes and results. Stevia offers great

potential for reformulation in a wide range of

food categories, such as dairy, beverages

and even confectionery. The promise of

naturally sourced, calorie-free sweetness is

incredibly attractive to consumers, although

manufacturing to meet their needs and

negotiating a market of many options and

myriad claims is a complex challenge.

For more informationHenry HussellHead of Marketing, Cargill Sweetness EMEATel. +32 154 00 411www.cargill.com

www.nutraceuticalmag.com January/February 2012

30bone and joint health

For those who desire a natural approach

to maintaining healthy bones and

joints, there are numerous products

designed to address the challenges

that compromise skeletal health, making this

category of products one of the largest within

the dietary supplement industry. As a result, the

consumer may face a difficult task in selecting

the best products. Fortunately, there are bone

and joint health products that do stand out from

the plethora of products on the shelves — and

they contain ingredients that exhibit impressive

efficacy, are extensively researched and are

derived from a renewable US food source: the

humble hen’s egg.

Natural Eggshell Membrane Joint comfort is important to all of us; even

the basic movements required to engage in

normal activities depend upon joint flexibility

without pain. Unfortunately, there are many

diverse factors that can place stress on our

joints, including an active lifestyle, excess

weight, family history and the ageing process.

Most dietary supplement products designed

to support joint health contain glucosamine or

chondroitin, or both, frequently in combination

with other dietary ingredients, such as MSM,

hyaluronic acid and various anti-inflammatories.

Research support demonstrating the benefits

offered by these products has been mixed, but

generally positive in the long-term. However,

the required dosage is relatively high, it takes

several months for the positive effects to be

experienced; for some, the benefits are less

than remarkable.

Natural eggshell membrane (NEM) is an

alternative choice for supporting joint health.

NEM is derived from the inner membrane of hen

eggshell that is situated between the portion

typically consumed as food (the egg white and

yolk) and the hard outershell. It is a unique,

naturally occurring source of several noteworthy

glycosaminoglycans (GAGs), including

chondroitin and hyaluronic acid, as well as

collagen, other beneficial proteins and amino

acids that are integral to joint health.

NEM is unique in other ways as well. Not

only does it provide important building blocks for

healthy joints, but it may also help to facilitate a

healthy inflammatory response. In vitro data has

shown that NEM decreases pro-inflammatory

biomarkers, including IL-1α, IL-1, MIP-1α,

MIP-1β, TNF-α and VEGF. More importantly,

the research support for NEM is impressive,

not only demonstrating that it works as well as

or better than other therapeutic ingredients in

this category, but also because it offers some

distinct additional advantages.

The results from two open-label studies

demonstrated the positive effects of natural

eggshell membrane in enhancing joint

comfort and flexibility.1 Each study evaluated

levels of pain, with one also evaluating

improvements in range of motion and in

both a single daily 500 mg dose of NEM

resulted in a significant response at the

end of the 7 day treatment. In a separate

randomized, multicentre, double-blind,

placebo-controlled clinical study, 500 mg

of NEM was found to statistically reduce

both pain and stiffness in patients with knee

osteoarthritis in as little as 10 days.2 This

positive benefit continued throughout the

duration of the study (60 days).

This clinical study also revealed that NEM

showed clinically meaningful results from a brief

responder analysis, the NNT (Number Needed

to Treat), a widely accepted and statistically

valid measurement used in clinical practice to

determine the effectiveness of a healthcare

intervention — in this study the parameter

measured was pain reduction. For a treatment

to be deemed effective, one out of every five

patients should experience at least a 50%

reduction in pain within 30–60 days. The lower

the NNT, the better the treatment modality is

judged to be. The NNT for NEM was 5.0 (60

days), which was much better than the NNT for

a combination of glucosamine/chondroitin or

for celecoxib (Celebrex), an NSAID commonly

used to treat the symptoms of arthritis and

other joint disorders. The NNT values for

stiffness, measured at 10, 30 and 60 days,

were equally as striking, particularly at the 60

day point, when the NNT was 2.4.

No participants experienced the gastric or

cardiovascular side-effects often associated

with NSAIDS, an important result not only

for individuals with arthritis, but also for

those who regularly engage in sports or

other athletic activities and experience the

joint discomfort, inflammation and stiffness

resulting from frequent joint motion. It is

notable that all these studies utilized the

relatively small single 500 mg dose of NEM,

compared with the 1500 mg recommended

dose for glucosamine products, which is

typically split into three 500 mg doses. The

recommended dosing for chondroitin is 1200

mg, also split between three 400 mg or two

600 mg doses.3 In terms of convenience,

NEM provides a preferable alternative.

The safety profile for NEM is also significant;

with the exception of those with known egg

allergies, there are no known adverse effects

associated with the use of NEM, even after

long-term use. This is especially important

for individuals suffering from conditions that

warrant extended use, in addition to those

who want to remain active into middle age and

beyond. NEM is self-affirmed GRAS, produced

in a GMP facility in the US and contains no

lactose, gluten, MSG, salt, sugar, artificial

colours, flavours, sweeteners or chemical

preservatives, additives or fillers.

wALkING ON EGG sHELLsThere is no doubt that an optimally functioning skeletal system is crucial for overall health and vitality: strong bones, flexible joints and healthy soft tissue work together to support movement and facilitate an active lifestyle. Most of us recognize the tremendous benefits of staying active and for many this includes doing what we can to strengthen our skeletal system, with the goal of avoiding the disease and injury that can detrimentally affect our bones and joints and disrupt our way of life.

January/February 2012 www.nutraceuticalmag.com

31bone and joint health

Eggshell Calcium for Bone HealthOsteoporosis and other disorders characterized

by a weakening or loss of bone mass are

increasing in prevalence — and the increase

isn’t entirely a result of our ageing populations.

Most people under the age of 50 give

little thought to their risk of hip fractures or

developing osteoporosis; we tend to think of

these issues as affecting the elderly, specifically

post-menopausal, small-boned women.

However, bone disorders don’t suddenly

become an issue when we reach a certain age

and definitely aren’t limited to a particular group

of individuals. Bone loss may accelerate more

rapidly in women, especially after menopause,

but past the age of 20, most of us, both men

and women, will start to lose more bone than

we make.4 This natural bone loss is more

pronounced in women and as a result of several

environmental and lifestyle factors, physicians

are beginning to report signs of low bone mass

in women in their 20s, 30s, and 40s — this

trend should be a concern for all of us.

We can’t control all the factors that can

harm our bones, but we can control our diet,

exercise plan and our choice of the right

bone-support supplement to ensure that we

are doing what we can to maintain the health

of our skeletal structure. In selecting the

best bone support product, it is important to

consider several factors. Most importantly, an

ideal bone support product should contain a

source of calcium that has been researched

and shown to not only be readily absorbed

into circulation from the GI tract, but also

functions to increase bone mineral density

(BMD). Eggshell calcium (ESC) provides these

advantages and more; the calcium derived

from eggshells is a natural food source,

containing a high content of elemental calcium

that is readily absorbed through the intestinal

tract. It is a non-mined, environmentally

friendly renewable source of calcium and

doesn’t pose the risk of containing significant

quantities of heavy metals such as arsenic, lead or

mercury, found in many other calcium sources.

A significant number of calcium supplements

contain calcium in the form of calcium

carbonate. This has the advantage of

containing considerably more elemental calcium

than other forms, such as calcium citrate or

calcium gluconate, so a smaller dose is needed

to provide the recommended daily value. In

many cases however, this advantage is offset

by its poor absorbability. Most supplements

containing calcium carbonate require gastric

acid to properly dissolve (ionize) it to be readily

absorbed through the intestinal wall into

circulation. Therefore, it is recommended that

calcium carbonate supplements be taken with

food to increase the levels of gastric acid, which

is in itself is somewhat problematic, as calcium

carbonate is a gastric acid neutralizer. Individuals

who frequently use acid neutralizing medications

or who have low stomach acid are usually

advised to select another form of calcium.5

Other calcium sources, such as calcium citrate,

are more readily absorbed but contain less

than 25% elemental calcium, necessitating a

much larger dosage in either the number or

size of tablets and capsules to achieve the

recommended daily dose.

ESC is unique; it has a high content of

elemental calcium — approximately 40% —

which is readily absorbed, whether taken with or

without food. This is in part owing to the natural

presence of transport proteins that facilitate

intestinal absorption.6 In addition, ESC is better

tolerated than other forms of calcium and is

less likely to cause constipation or the other

GI symptoms that are a common complaint of

those taking calcium supplements. The benefits

of ESC are supported by research that reveals

its positive impact on bone mineral density.

Published results from several research studies

demonstrated that supplementing with ESC,

along with magnesium and vitamin D3, resulted

in an improvement in BMD by up to 6% in a

relatively short time (4–8 months) in patients with

osteoporosis.7 Not only is ESC readily absorbed

but also functions quickly and effectively to

improve bone density.

Protecting the body’s skeletal system is a

goal that can only be accomplished through

high levels of dedication. Selecting the right

joint and bone health supplements is integral

to this process. If ingredient priorities include

proven safety with GRAS status, a US supplied

renewable and environmentally friendly source,

well-researched efficacy substantiation and

guaranteed testing for contaminants including

heavy metals and microbes, then NEM and ESC

are the obvious choices for supporting joint and

bone health.

References1. K.J. Ruff, et al., “Eggshell Membrane: A Possible New

Natural Therapeutic for Joint and Connective Tissue Disorders. Results from Two Open-Label Human Clinical Studies,” Clin. Interv. Aging 4, 235–240 (2009).

2. K. J Ruff, et al., “Eggshell Membrane in the Treatment of Pain and Stiffness from Osteoarthritis of the Knee: a Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Study,” Clin. Rheumatol. 28(8), 907-914 (2009).

3. http://www.mayoclinic.com/health/chondroitin-sulfate/NS_patient-chondroitin/DSECTION=dosing

4. Natural Osteoporosis Foundation: http://www.nof.org/aboutosteoporosis/bonebasics/howbonesgrow

5. http://ods.od.nih.gov/factsheets/calcium6. W. Daengprok, et al., “Chicken Eggshell Matrix

Proteins Enhance Calcium Transport in the Human Intestinal Epithelial Cell, Caco-2,” J. Agric. Food. Chem. 51(20), 6056–6061 (2003).

7. J. Rovensky, et al., “Eggshell Calcium in the Prevention and Treatment of Osteoporosis,” Int. J. Clin. Pharmacol. Res 23(2–3), 83–92 (2003).

For more informationHeather ThompsonGlobal Marketing CommunicationsStratum Nutrition heather.thompson@stratumnutrition.comwww.stratumnutrition.com

www.nutraceuticalmag.com January/February 2012

32 bone and joint health

This, however, does not have to be the case. Elderly consumers can

take control of their health — and possibly stave off osteoporosis —

by leveraging their diet’s role in preventing it. As scientists study the

relationship between diet and osteoporosis, they’re learning that the

antioxidant lycopene may help us reduce risk and improve our new old age.

Stealthy ConditionWhat sets the new old age apart is that its characteristic health issues are

no longer the acute diseases that put our grandparents in early graves.

Instead, chronic concerns — diabetes, heart disease, hypertension,

arthritis and so on — follow us well into our golden years precisely

because they’re not fatal. We’ve learned to manage them for the

long-term, even if we can’t cure them outright. Such is the case with

osteoporosis, a disease in which low bone mass and the progressive

weakening of the bone’s architecture result in increased risk of fracture.

It is a stealthy condition and sufferers often don’t know that they have it

until they experience their first bone break. In advanced cases, even a light

bump of the furniture or a hearty cough can bring about fracture.

Osteoporosis is of particular concern to menopausal women

because the hormone oestrogen increases bone density, halting

the natural process of bone breakdown known as resorption. As a

result, when oestrogen levels drop during menopause, bones lose an

important protector and strengthening agent. The increasing number

of women now reaching menopausal age will be mirrored by an

increasing number becoming susceptible to the fragility and fractures

that make osteoporosis so incapacitating individually and so costly to

society at large.

A Global BurdenIn fact, according to the International Osteoporosis Foundation (IOF), the

disease already affects an estimated 75 million people in Europe, the US

and Japan and its burden on healthcare systems will only increase in line

with the global elderly population. In the US, the National Osteoporosis

Foundation predicts that the cost of osteoporosis will reach $25.3 billion

by 2025 and the IOF reports that, in Europe, levels of osteoporosis-

related disability already exceed those caused by cancers (with the

BuILDING BONEs sTrONGEr, FOr LONGErThey say that 70 is the new 50 — and to watch senior citizens “going for the burn” at the local gym

or doing battle on the tennis courts, they appear to be right. Adults entering their golden years today

have more to look forward to than any previous generation. Medical science, improved preventive care

and nutritional and pharmaceutical interventions for everything from high cholesterol to garden-variety

fatigue not only help us to live longer, they also help us to live better. Yet even as today’s elderly remain

active and independent well into their seventh or eighth decades, all it takes is one fall or fracture to rob

them of their independence, bring their hard-earned vitality to a halt and remind us all that even this “new

old age” is accompanied by osteoporosis and fragility that can still put us out of commission.

January/February 2012 www.nutraceuticalmag.com

33bone and joint health

exception of lung cancer) and are comparable with or greater than

the disabling effects of chronic diseases such as rheumatoid arthritis,

asthma and hypertension-related heart disease.

Although osteoporosis has entered the public consciousness as a

“women’s disease,” neither gender is spared by the condition. The IOF

estimates that osteoporotic fracture will strike one in five men who live

past the age of 50, compared to one in three women of the same age

group, and that by 2050 the worldwide incidence of hip fracture in men will

increase by 310% and 240% in men and women, respectively.

More than MineralsIt is no surprise that so much money and effort has gone into

understanding the progression, treatment and prevention of

osteoporosis. When that research has focused on nutritional factors,

it has usually, and not without reason, turned its attention to calcium.

The body stores about 99% of its calcium in the bones, where it forms

a critical component of hydroxyapatite, a calcium-phosphate complex

that gives bone its structural rigidity. Calcium alone, however, can

neither prevent nor cure osteoporosis.

Protein, which constitutes up to 22% of bone by weight and 50% by

volume, is also involved, serving as a matrix in which minerals embed.

The body thus needs a steady supply of top-quality protein for bone

maintenance, especially as we age. Despite some studies showing that

high intakes of animal protein may trigger calciuria, or excess calcium in

the urine, other research points out that a high-protein diet can actually

increase intestinal calcium absorption. Then there’s vitamin D, which supports

calcium metabolism and its incorporation into the skeletal structure. In

children with severe vitamin D deficiency, bones inadequately mineralize,

retarding growth and leading to the pain and deformity of rickets. Once

a rare deficiency in the developed world owing to its presence in fortified

foods and capacity to form in the skin when exposed to sunlight, public

health efforts to discourage sun exposure have inadvertently reinstated

vitamin D on the ‘vitamins of concern’ list.

Oxidation OffensiveAside from vitamin D, protein and calcium, do other nutrients hold promise

as a dietary check on osteoporosis? In fact, some do. Antioxidants have

long attracted notice for stemming the progress of chronic, oxidation-

related diseases such as atherosclerosis, neurodegenerative disorders and

some forms of cancer. Now researchers are investigating whether they

can combat the oxidative component of osteoporosis. Scientific literature

demonstrates such a component in the development of osteoporosis;

oxidative stress induced by free radicals increases bone loss, with high

concentrations of free radicals weakening and killing the osteoblast

cells that promote bone synthesis, and promoting the formation of the

osteoclasts responsible for bone resorption. Researchers have also found

epidemiological evidence of an inverse relation between oxidative stress

biomarkers and bone mineral density.

In examining the antioxidant concentrations of women with and

without bone loss, several case-controlled studies have found there to

be less antioxidant activity in those with osteopenia — a condition of

low bone density that falls short of osteoporosis — than in their healthy

postmenopausal counterparts. This may reflect the body’s endogenous

antioxidant system kicking into overdrive in osteopenic women to “turn off”

resorption-promoting osteoclasts.

The Lycopene LinkAs osteopenia progresses to osteoporosis, our internal defenses appear

to become overwhelmed, allowing oxidation and subsequent bone loss

to proceed. This raises the question of whether, when our endogenous

antioxidants fall short, dietary antioxidants can step in — and researchers

are optimistic that they can. Although the supporting science is still in its

infancy, the carotenoid antioxidant lycopene, a pigment found in tomatoes,

watermelon and other red foods, has been the subject of considerable

excitement as a result of its potential to reduce the risk of osteoporosis.

Lycopene appears to inhibit osteoclast formation and subsequent

free-radical production in vitro, reducing the rate of bone resorption.

www.nutraceuticalmag.com January/February 2012

34bone and joint health

Furthermore, in human and mouse models the carotenoid’s effect on

osteoblasts appears to be stimulative, boosting growth, differentiation

and activity. Researchers have observed a positive association

between lycopene status and bone mineral density and postulate that

the correlation may contribute to a reduced risk of osteoporotic frailty

and fracture.

The State of the ScienceA US Department of Agriculture-funded longitudinal dietary study,

published in 2009 in the Journal of Bone and Mineral Research, followed

participants in the Framingham Osteoporosis Study for more than

15 years and found that those with a high lycopene intake —

12.7 mg/day — suffered significantly fewer non-vertebral osteoporotic

fractures compared with participants who consumed only 2.7 mg of

lycopene daily. When the researchers examined the relationship between

hip fractures and consumption

of lycopene-rich foods, they

found that subjects who

ate at least 4.4 servings

of certain foods such as

tomatoes, tomato juice and/

or sauce, grapefruit, pizza and

watermelon per week had

significantly fewer hip fractures

than those who consumed

such foods at a rate below

4.4 servings weekly.

Moreover, they observed

no such associations for

the antioxidants beta-

cryptoxanthin, lutein,

zeaxanthin or alpha- or

beta-carotene, hinting that

lycopene may be unique

among carotenoids in its effect on osteoporosis risk reduction.

A more recent dietary study examined bone resorption rates,

antioxidant activity and oxidative stress markers to measure the effect

of dietary lycopene on osteoporosis risk. In the first month of the

study, 60 postmenopausal women aged 50–60 years consumed no

lycopene at all. Then the researchers randomly assigned the women to

4 month long, twice daily regimens of ordinary tomato juice, lycopene-

enhanced tomato juice, a tomato lycopene Lyc-O-Mato capsule or

a placebo. Following treatment, those on the lycopene regimens

showed not only increased antioxidant activity relative to those taking

the placebo, but decreased levels of markers for both oxidative stress

and bone resorption. The study was published online in Osteoporosis International in June 2010.

An even more recent research abstract published in 2011 in the journal

Bone followed 440 healthy, postmenopausal women, each of whom

supplied the researchers with 4 day diet diaries and blood and urine

samples. The researchers measured the women’s bone mineral density at

five sites using dual-energy X-ray absorptiometry and found that women

with higher dietary lycopene intakes not only exhibited higher serum

lycopene levels, but that those levels translated into significant increases

in bone mineral density and formation, and decreases in bone resorption

biomarkers. Women in the higher dose lycopene groups also displayed

improved oxidative stress parameters. The results led researchers to

conclude that the dietary antioxidant lycopene may help to decrease the

risk of bone loss and osteoporosis.

Bones and BeyondResearchers are still trying to tease out the mechanisms by which lycopene

achieves these benefits, but most proposed modes of action thus far focus

on the carotenoid’s potent antioxidant capacity. This comes as no surprise

to Dr Yoav Blatt, chief technology officer at LycoRed, who commented:

“It just makes good sense; during the past few decades, what we’ve

learned about disease prevention and antioxidants — and lycopene in

particular — has been game-changing. When you look at how lycopene

reduces the oxidative stress related to risk for cardiovascular disease,

cancer, hypertension, diabetes and even male infertility, a role for lycopene in

preventing bone loss and osteoporosis almost seems the next logical step.”

As the science surrounding lycopene and bone health matures, so will

the public’s interest in the relationship grow. Why? Because, as Blatt points

out, today’s seniors are a savvy lot when it comes to their personal health

and arm themselves with information about conditions that concern them,

whether that be by following

medical websites, gleaning peers’

experiences from social media or

simply quizzing their own medical

professionals. “If news arises that

links lycopene to improved bone

health,” Blatt says, “you can bet

they’ll be on it.”

This opens the door for

product developers to design

foods and beverages that

directly target this educated,

health-aware community.

Consider a beverage that bills

itself as a ‘bone-health cocktail;’

in addition to soy or dairy

protein and calcium, it might

deliver natural, tomato-sourced

Lyc-O-Mato, which is not only

specially formulated for water-solubility but contains the full complement

of naturally occurring carotenoids, in addition to lycopene. Blatt continues:

“Then, for the beverage’s vitamin D component, you could use our

CapsuDar D3 CWD ingredient — we designed it to dissolve instantly and,

by encapsulating it, we protect it against light, oxidation and acid. What

we really think is exciting about the ingredient, however, is that it goes into

solution in beverages with crystal clarity, which means that this fat-soluble

vitamin can now be invisible, even in flavoured waters.”

By formulating with nutrients that address seniors’ bone health concerns,

you can reach a consumer base that’s eager to be addressed. Blatt has

seen this firsthand: “Our research shows that today’s older consumers are

hungry — or thirsty, if you like — for products that are relevant to them,” he

says — “that means designing for bone health benefits.” In addition, they’re

less price-sensitive when these products offer benefits backed by sound

science, as well as the required great taste and texture. “It’s their health,

after all,” Blatt points out, “if we in the food industry can help to improve

it, and maybe even save consumers money relative to expensive medical

treatments, I think we’re getting the ball rolling in a positive direction.”

For more informationKarina Munch BedrackSales ManagerLycoRed Bio LtdTel. +972 732 327 500info@lycored.comwww.lycored.com

January/February 2012 www.nutraceuticalmag.com

Discover the world of ingredients forNutraceuticals I Functional foods I Functional drinks I Dietary supplements

Portfolio includes: Organised by:

Register now at www.vitafoodssouthamerica.com/nbt

• Debate with peers at the Discussion Forum

• Free EAS Advisory Sessions

• Networking opportunities

• Market and trend forecasts

And much more...

Trade show and conference including:• Meet over 75 international ingredients

and raw materials suppliers

• 2-day scientific conference

• Discover the New Products Zone

FREE

TO ATTEND

REGISTER N

OW

Supported by:

28-29 March 2012 I Frei Caneca Convention Center I São Paulo, Brazil

www.nutraceuticalmag.com January/February 2012

Affecting approximately 30 million

people in the US alone, osteoarthritis

(OA) is the most prevalent chronic

joint disease, with a rising global

incidence that is ensured by an ageing

population and an obesity epidemic.

Diverse treatment options that include

pharmacological, non-pharmacological and

surgical approaches are available to manage

the main clinical features, such as pain and

loss of joint function — they have, however,

shown limited success. The pharmacological

option in particular is accompanied by

serious gastrointestinal and cardiologic side-

effects, which, aside from the heavy financial

burden, make it unfit for a safe and long-term

approach.

Despite some of their number displaying

efficacy in human clinical trials, the outcome

of non-pharmacological options, such as

dietary supplements, remains inconclusive.

One reason for this disappointment is

that current OA treatment options fail to

address the complexity of osteoarthritic

pathogenesis, which involves abnormal

signal transduction in various cells found in

the cartilage, synovium and subchondral

bones. At a molecular level, OA is

accompanied by the disruptive turnover of

extracellular matrix (ECM) in the cartilage;

catabolic changes in ECM are mediated

not only by the secretion of inflammatory

mediators but by the disorganization,

fragmentation and eventual loss of collagen

fibres and proteoglycans such as aggrecans

(a multi-molecular complex of glycoproteins

and GAGs). Additionally, OA is associated

with the reduced lubricating capability of the

synovial fluid, which is likely to result from

the breakdown of HA. Thus, any effective

treatment should be able to address these

multi-faceted aspects of OA to halt or modify

its course, while providing relief from its

debilitating symptoms.

Partial versus Comprehensive Dietary ApproachDietary ingredients subjected to human

clinical trials that have shown potential in

managing OA-associated symptoms include

glucosamine, chondroitin sulfate, avocado

soybean unsaponifiables (ASU), pycnogenol

and collagen (in both undenatured and

hydrolysed forms). Although clinical relevance

and biological mechanisms are yet to be

established, the finished products that contain

these ingredients appear at least to be safer

than their pharmacological counterparts, in

addition to reducing some of the debilitating

OA symptoms. Among these ingredients,

glucosamine and its combination with

chondroitin sulfate lead the market. However,

a recent meta-analysis of the ten largest

clinical trials performed under high-standard

clinical protocols demonstrated that its

efficacy in reducing OA-associated pain

was seriously called into question, as data

A HOLIsTIC APPrOACH TO JOINT HEALTH

January/February 2012 www.nutraceuticalmag.com

37bone and joint health

Figure 1: Bioavailablity of LMW HA in hydrolysed chicken sternal cartilage extract.

obtained from more than 3000 OA patients

failed to show a statistical significance of

pain-reducing effect as compared to placebo.

A plausible explanation may be that the two

ingredients act on the complex pathological

process in the cartilage only by supplementing

GAGs and fail to address the more important

issue: the loss of the collagen fibre network.

As previously stated, OA is a dynamic and

complex disease that involves the degradation

of ECM in the cartilage that comprises both

collagen (primarily type II) and non-proteinous

molecules such as GAGs — and thus

requires a more comprehensive approach to

counteracting the degenerative process.

Chicken Sternal Cartilage Mirrors Human CartilageOA is also termed a ‘wear and tear’ disease

of the articular cartilage of the synovial

joint; the most common and active joint in

the human body. Aside from water, which

comprises 70–80% of human cartilage,

collagen and proteoglycans are its major

components, each assuming 10–20% of the

avascular glossy covering of the underlying

subchondral bone, followed by the

chondrocytes, which produce and maintain

the cartilage ECM and comprise 1–5%

of it. Proteoglycans are a multi-molecular

complex of glycoproteins with GAGs such as

HA, keratin sulfate and chondroitin sulfate,

which are immobilized into the collagen fibre

matrix. The nature of this complex network of

diverse molecules implies that an ingredient

made from the same type of cartilage can

offer a more effective nutritional approach to

OA than glucosamine or its combination with

chondroitin sulfate.

Classified as an articular cartilage — and

with a composition of collagen type II and

GAGs that mirrors that of human articular

cartilage — chicken sternum cartilage is

a potential solution. Furthermore, recent

research on hydrolysed collagen and GAGs

has suggested that hydrolysed chicken

sternal cartilage extract containing LMW

GAGs, as well as hydrolysed collagen type II

(MW of 1.5–2.5 kDa), appears to harbour

diverse biological properties — in addition

to enhanced bioavailability — that not only

make it relevant to a comprehensive

dietary support for OA-associated

symptoms but offer a possible disease-

modifying effect through a potential

regeneration of the cartilage.

Hydrolysis Enhances BioavailabilityA number of collagen types have been found

in the human body, with types I, II, and III

being predominant. Collagen type II is specific

to the articular cartilage, constituting more

than 90% of collagen in the tissue, whereas

types I and III are abundant in the skin dermis.

Most collagen is found as a macromolecular

triple-helix form that is poorly soluble in its

native or undenatured state. Hydrolysing this

macromolecule sufficiently to reduce its MW

substantially, depending upon manufacturing

protocols, results in a collagen that becomes

much more soluble.

The most direct effect of the hydrolysis

process is to increase the collagen’s

bioavailability — as demonstrated by a

study using a mouse model, which revealed

that more than 90% of hydrolysed collagen

was absorbed into the small intestine. A

separate study, which used human subjects,

demonstrated that hydrolysis of the chicken

sternal cartilage not only reduced the MW of

the collagen type II but also depolymerized

the HA (a macromolecule with a native MW

that ranges higher than 1x106 Da) into shorter

chain LMW fragments. When hydrolysed

chicken sternal cartilage extract containing

the LMW HA is ingested, the latter greatly

increases its levels in the human blood

compared with its baseline, thus suggesting

that LMW HA is also highly bioavailable

(Figure 1). Several patents exist surrounding

this invention and have been assigned to

BioCell Technology, LLC.

Synergy of Multiple Biological Properties A neglected issue in the discussion

of a dietary ingredient’s efficacy is its

pharmacokinetics — its absorption,

distribution and metabolism — which affects

both its bioavailability at the target tissue

and its eventual health benefits. Although a

number of ingredients display their exciting

potential in in vitro cell-based studies, most

of these fail to demonstrate their presumed

physiological effect as a result of their short

half-life in vivo. The hydrolysed type II collagen

and LMW HA contained in hydrolysed

chicken cartilage extract is unique in that

these important issues have been addressed

relatively well by independent studies.

• First, in a mouse model, the majority of

radiolabelled hydrolysed collagen was

absorbed through the gastrointestinal

tract and found to be accumulated in the

cartilage in the long-term, suggesting that

the metabolites of ingested hydrolysed

collagen reach the target site of action.

www.nutraceuticalmag.com January/February 2012

38bone and joint health

• Second, human ingestion of hydrolysed

chicken cartilage extract led to the

appearance of many different forms of

collagen-derived peptides, among which

the dipeptide, Pro-Hyp, was predominant.

Studies suggested that this dipeptide

was biologically active in vivo and exerted

multiple physiological effects; for example,

the articular cartilage of mice fed with

Pro-Hyp in an OA-inducing, phosphorus-

containing diet showed a significantly lower

degree of cartilage degradation than control

mice. There was also a reduced level of

death of the chondrocytes, suggesting that

this dipeptide provided a chondroprotective

effect. An alternative study revealed that

the biosynthesis of HA was stimulated from

the synovium cells and that, moreover,

the collagen-derived Pro-Hyp stimulated

the proliferation of the dermal fibroblasts.

This is particularly intriguing as the cells’

senescence is considered to be an

important underlying cause of the dermal

breakdown of collagen fibres in skin ageing.

• Third, hydrolysed collagen — not the native

or undenatured form of collagen — was

shown to stimulate the chondrocytes to

produce and secrete collagen type II and

proteoglycans, with hydrolysed collagen

type II from chicken sternums displaying

higher activity than hydrolysed collagen

type I. This in vitro study suggests a

possible positive feedback mechanism for

the regulation of collagen turnover in the

cartilage, which has significant ramifications

for the use of the extract in rebuilding

degraded cartilage.

• Fourth, hydrolyzed chicken sternal cartilage

extract was shown to inhibit hyaluronidase

in vitro, in a dose-dependent manner

(Figure 2). Hyaluronidase contributes to

ageing processes in the skin by degrading

HA, which has its ability to bind water

attenuated by a shortened chain length

and decreased polyanionic charge. The

loss of the amount and integrity of HA may

lead to weakened joint lubrication and

dampened resistance to compressive forces

applied to the cartilage. Given the fact

that hyaluronidase-mediated degradation

of HA is implicated in ageing and

inflammation, the ability of this extract to

inhibit it may have profound implications

for the ageing processes that take place in

the joints and skin.

Human Clinical TrialsThis dietary ingredient boasts multiple

mechanisms of action that indicate a

potential holistic approach to joint health. A

randomized, controlled human clinical trial is

the gold standard in investigating the clinical

relevance of the bioavailability and biological

properties of the LMW hydrolysed chicken

sternal cartilage extract to the effective

management of OA-associated symptoms.

There have previously been clinical studies

demonstrating the safety and beneficial

effects of hydrolysed collagen, in addition

to GAGs, with respect to chronic arthritic

joint conditions, including OA. Only recently,

however, was a study performed on a dietary

ingredient containing both hydrolysed collagen

and GAGs such as HA. The clinical trial of

LMW hydrolysed chicken cartilage extract

revealed its safety and significant efficacy in

managing OA-associated conditions — and

thereby its potential to enhance the quality of

daily life. Its daily ingestion for 8 weeks led to

a significant difference in the reduction of the

WOMAC (Western Ontario McMaster University

Osteoarthritis) score — the composite of

the efficacy endpoints for pain, stiffness

and physical difficulties — compared with

placebo (Figure 3). At the end of the study, the

difference between the two groups’ scores was

approximately 40%, suggesting that this novel

ingredient that provides a synergy between

hydrolysed collagen type II and LMW HA is a

strong candidate for a holistic solution to this

complex and dynamic joint disease.

A Holistic Approach and BeyondCollagen and GAGs are found in the ECM

of virtually every connective tissue, including

cartilage, tendon, ligament, blood vessel and

skin dermis. Their efficacy for joint health has

been well documented by clinical trials, as

discussed above, and recent experimental and

clinical skin studies have provided evidence for

their positive effect on skin ageing. For example,

in an animal model study, hydrolysed collagen

led to an increase in the number of dermal

fibroblasts and the diameter of collagen fibrils

in the ECM of the skin dermis. Hydrolysed

collagen can also protect the skin from UV

damage such as epidermal hyperplasia and the

loss of collagen type I. In addition, the Pro-Hyp

dipeptide that appears in human blood after

ingestion of hydrolysed chicken cartilage extract

was shown to enhance the biosynthesis of HA

from the dermal fibroblasts.

It can be hypothesized that ingredients

containing both hydrolysed collagen and

GAGs can be relevant to other connective

tissues, such as tendons and ligaments, as

these molecules are also essential for their

structure and functions. Further studies are

warranted to investigate their effect on these

and other connective tissues, which will prove

whether this unique ingredient can offer a

holistic solution to ageing-associated joint,

skin and connective tissue problems.

For more informationDr Joosang ParkVice President of Scientific AffairsBioCell Technology, LLCTel. +41 7146 321 231joosang@biocelltechnology.com www.BioCellTechnology.com

Figure 2: Inhibition of hyaluronidase.

Figure 3: Improvement of OA-associated symptoms.

This dietary ingredient boasts multiple mechanisms of action that indicate a potential holistic approach to joint health.

January/February 2012 www.nutraceuticalmag.com

Evolutionary,Revolutionary,Introducing Nexira

A new creation is emerging from nature…

CNI, global leader in acacia gum, and Bio Serae, premier supplier of nutraceutical ingredients, combine their skills to become Nexira. The synergistic growth of Nexira will provide customers additional advantages:

• Innovative ingredients portfolio – functional & nutraceutical benefits

• Strong technical service and formulation support• Proprietary processing technologies• Global supply chain assurance• Regulatory leadership

Customers can be certain that Nexira will continue to provide excellent service, maintaining the reputations of both CNI and Bio Serae.

Learn more about Nexira at:www.nexira.com

Visit us at FIE: Booth 3D33

1110 Pub Nexira_NBT.indd 1 20/10/2011 08:56:23

www.nutraceuticalmag.com January/February 2012

40 bone and joint health

Although gut and digestive health

claims remain the most popular to

be appended to functional dairy

products, there is considerable

ongoing interest in bone health. Bone health

or added calcium claims (or both) featured

in more than 17% of dairy launches on an

active health platform in the 12 months

to the end of June 2011, or 4% of dairy

launches as a whole (as recorded on the

Innova Database). The majority of bone

health launches in the sector were in dairy

drinks or dairy alternative (mainly soy)

drinks, which accounted for more than two-

thirds of the total, well ahead of yoghurt,

which accounted for slightly more than 15%.

Dairy products marketed on a bone

health platform have become increasingly

sophisticated in recent years. Originally their

primary focus was a naturally high calcium

content or calcium fortification and they

largely relied on consumer awareness of the

mineral’s benefits; recently, however, these

products have made greater use of

ingredient blends that go beyond

calcium, including ingredients that

help to boost calcium absorption

and bone formation, such as

vitamin D. Ingredients now

promoted in bone health

applications include vitamin

K2, lysine, prebiotic fibres

and soy isoflavones.

Functional drinking milks

have traditionally focused

on added ingredients (such

as vitamins, minerals,

probiotics) and a general health positioning

rather than using more specific health

claims. As a result, they have not always

been regarded as functional in the strictest

sense of the word. However, the number

of more specialist milks being launched is

changing this, although the market remains

fairly fragmented and highly regionalized,

with countries such as the US and Spain

having large markets that partially reflect

large liquid milk consumption levels. Spain

has one of the largest European markets

for vitamin and mineral enriched milks,

with particular strength in calcium fortified

products. The first of these was introduced

to the Spanish market by Puleva in 1993 —

this triggered a burst of activity in fortified

milks that built the market to its current

level (calcium-enriched lines accounted for

more than 16% of the Spanish milk market

in 2010). Product activity in calcium milk

now focuses more specifically on bone

health ingredients used in conjunction

with calcium, as demonstrated

by Puleva’s introduction

in late 2010 of its Calcio

con Isoflavonas de Soja — a

skimmed milk with calcium and

soya isoflavones.

In the yoghurt market,

meanwhile, specialist

bone health products

are starting to appear

in Europe, with recent

activity being led by

Danone and its Densia

yoghurt with added

calcium and vitamin D. It was launched

in Spain in 2009 and, unlike most added

calcium products in the past that have

been aimed at the children’s market, was

targeted at older women. It met with some

initial success in Spain and has since been

launched in Portugal and Italy, where it is

called Danaos. Testing of Densia in France,

however, proved disappointing and it was

not launched onto the French market. In

2011 it was introduced in Brazil, both in

the more common spoonable format and

as a dose-delivery drink.

Interestingly, General Mills — which has

just purchased a 51% controlling share in

Yoplait, the world’s number two yoghurt

brand — announced in July 2011 that it was

looking for new ingredients or technologies

for fermented dairy products. The goal

is to move “beyond the known impact of

calcium and vitamin D” in boosting the bone

formation process, in addition to looking at

solutions to increase calcium absorption.

Lu Ann Williams, research manager at

Innova Market Insights, contends that,

despite some of the problems caused

by the economic downturn, consumer

confusion and ongoing regulatory issues,

the potential for functional lines such

as bone health dairy products remains

as strong as ever. She explains: “This

is being driven by ageing populations,

rising interest in healthy lifestyles and a

growing awareness of the link between

diet and health, supported by significant

investment by the food and drinks industry

in innovative product activity.”

BONE BOOm

For more informationLu Ann WilliamsInnova Market InsightsTel. +31 263 192 000contact@innovami.comwww.InnovaDatabase.com

January/February 2012 www.nutraceuticalmag.com

NUTRACEUTICAL BUSINESS & TECHNOLOGY

www.nutraceuticalmag.comWhere food and pharma meetNBT is your musT-read source of News, updaTes aNd developmeNTs iN The fuNcTioNal food, NuTraceuTical, dieTary supplemeNT aNd iNgredieNT iNdusTry.

Women’s HealtHSupplementing the fairer sex

w w w . n u t r a c e u t i c a l m a g . c o m

• ingredients • functional foods • nutraceuticals • supplements • raw materials •

ProbioticsRestoring the balance

Claims under pressure

cosmetic FocusMarketing products in Southern Africa

Functional bakery, sPorts nutrition, cognitive HealtH and more

Volume 7 Number 2 March/April 2011

See website for details on Awards and Exclusive Business Roundtabe

www.nbtawards.com

EXCLUSIVE EVENT

EXCLUSIVE ROUNDTABLE

EXCLUSIVE ROUNDTABLES

www.nutraceuticalmag.com January/February 2012

42 bone and joint health

The ageing process is said to bring

maturity and a wealth of experience,

but it can also lead to a decline

in health and vitality — sufficient

intake of essential nutrients, however, can

help older people to stay physically active

and get the most out of life. There is a rapidly

growing portion of the population that falls

into the over-65 age group, which is resulting

in a commercial renaissance for nutritional

products targeting the senior audience.

Osteoarthritis of the knee afflicts 40% of

people above the age of 70 worldwide;

80% of sufferers are forced to limit their

movements and 25% cannot perform basic

daily activities.1

A burgeoning demand for products

that provide effective joint relief is behind

the projected growth of the the European

and US joint health markets by 7–8%

and 6%, respectively.2 Joint relief

products, mainly comprising dietary

supplements and beverage applications,

are targeted predominantly at two

consumer groups: people above the age

of 50 and sports enthusiasts.

A joint is the point at which two or more

bones come together to facilitate movement

— healthy joints move smoothly, without pain

or swelling, owing to a complex system of

lubrication and shock absorption that acts

like a cushion and prevents excessive bone

friction. Products currently available on the

market are predominantly glucosamine/

chondroitin (GC) based, but new research has

revealed that they are not as effective as once

thought.3 The search for new solutions, has

led nutraceutical manufacturers to vitamins,

minerals and omega-3 fatty acids; according

to a number of studies, vitamin E, which is

found in the synovial fluid, helps to reduce

joint discomfort and low levels of vitamin

B6 are associated with pro-inflammatory

conditions that negatively affect joint health.4–7

In addition, vitamin D deficiency has been

linked to osteoarthritis and rheumatoid

arthritis.8–11 Regular consumption of omega-3

long chain polyunsaturated fatty acids (PUFAs),

primarily docosahexaenoic acid (DHA) and

eicosapentaenoic acid (EPA), has been shown

to reduce joint discomfort as a result of their

anti-inflammatory properties.12–14 A meta-

analysis of 14 clinical trials in patients with

rheumatoid arthritis or joint pain linked PUFA

supplementation with a significant decrease

in joint pain intensity, duration of morning

stiffness and number of sensitive joints.15 In

another study, a daily high dose of omega-3

supplements was found to decrease the

severity of symptoms associated with

ankylosing spondylitis, a chronic disease

that mainly affects joints of the spine and

hips.16 Equally, a high intake of vitamin C

substantially reduces uric acid concentration

in the blood and is associated with minimized

risk of gout.17

Adding Life to YearsThe ability to move unhindered by pain is

a fundamental part of maintaining quality

A JOINT EFFOrT

43bone and joint health

The Executive Advisory Board of the Vitafoods Europe Conference is now accepting papers for consideration for the 2012 Event.

For further details visit www.vitafoods.eu.com/nbtcall Or contact Lynne Evans at lynne.evans@informa.com

www.vitafoods.eu.com/nbtcall

In addition to traditional presentations, we would also like to receive:Scientific papers | commercial applications | new markets | business development case studies | latest research thinking | panel debates | new applications Q&A sessions | merger and acquisition strategy | growth strategies

Key topic areas include:

• Market for Aging Consumers • Gut Health • Mental Health • Joint Health

• Physical Performance• Food Allergy & Intolerance • Ingredients from Nature

Speake

r

Opportunit

ies

For more informationDSM Nutritional ProductsCharlotte FrederiksenTel. +41 6181 583 54charlotte.frederiksen@dsm.com www.dsm.com

References1. World Health Organization, “Chronic Rheumatic Conditions,” 2009 (www.who.int/chp/topics/rheumatic/en/).2. Frost & Sullivan, “European Bone and Joint Health Ingredients,” 31 March 2009 (www.frost.com/prod/servlet/report-

toc.pag?repid=M39C-01-00-00-00).3. J.E. Silbert, et al., “Dietary Glucosamine Under Question,” Glycobiology 19(6), 564–567 (2009).4. K. Fairburn, et al., “Alpha-Tocopherol, Lipids and Lipoproteins in Knee-Joint Synovial Fluid and Serum from Patients with

Inflammatory Joint Disease,” Clin. Sci. 83(6), 657–664 (1992).5. G. Blankenhorn, ”Clinical Effectiveness of Spondyvit (Vitamin E) in Activated Arthroses. A Multicenter Placebo-Controlled

Double-Blind Study,” Z. Orthop. Ihre Grenzge. 124(3), 340–343 (1986).6. N.H. Haflah, et al., “Palm Vitamin E and Glucosamine Sulphate in the Treatment of Osteoarthritis of the Knee,”

Saudi Med. J. 30(11), 1432–1438 (2009).7. Chiang EP, et al. “Pyridoxine Supplementation Corrects Vitamin B6 Deficiency but Does Not Improve Inflammation in

Patients with Rheumatoid Arthritis,” Arthritis Res. Ther. 7(6), 1404–1411 (2005).8. C. Ding, et al., “Serum Levels of Vitamin D, Sunlight Exposire, and Knee Cartilage Loss in Older Adults: the Tasmanian

Older Adult Cohort Study,“ Arthritis Rheum. 60(5), 1381–1389 (2009).9. S.K. Das, et al., “Osteoarthritis,“ Best Pract. Res. Clin. Rheumatol. 22(4) 657–675 (2008).10. T.E. McAlindon, et al., ”Relation of Dietary Intake and Serum Levels of Vitamin D to Progression of Osteoarthritis of the

Knee Among Participants in the Framingham Study,” Ann. Intern. Med. 125(5), 353–359 (1996).11. M. Mouyis, et al., “Hypovitaminosis D Among Rheumatology Outpatients in Clinical Practice,” Rheumatology 47(9),

1348–1351 (2008).12. D. S. Kelley, et al., “DHA Lowers Blood Triglycerides in Diet Study,” J. Nutr. 139(3), 495–501 (2009).13. M. Troseid, et al., “Serum Levels of Interleukin-18 are Reduced by Diet and n-3 Fatty Acid Intervention in Elderly

High-Risk Men Metabolism 58(11), 1543–1549 (2009).14. R.J. Goldberg, et al., “A Meta-Analysis of the Analgesic Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation

for Inflammatory Joint Pain,” Pain 129(1–2), 210–223 (2007).15. B. Sundstrom, et al., “Supplementation of Omega-3 Fatty Acids in Patients with Ankylosing Spondylitis,”

Scandinavian Journal of Rheumatology 35, 359–362 (2007).16. H.B. Stein, et al., ”Ascorbic Acid-Induced Uricosuria: A Consequence of Megavitamin Therapy,” Ann. Intern. Med. 84(4),

385–388 (1976).17. H.K. Choi, et al., “Vitamin C Intake and the Risk of Gout in Men: A Prospective Study,” Arch. Intern. Med. 169(5), 502–507 (2009).

of life. Strong joints help seniors to remain

independent and continue doing the things

they enjoy. DSM Nutritional Products offers

a wide range of high-quality micronutrients,

available in Quali Blends nutritional

premixes, which address all major causes

of joint discomfort and immobility. In one

easy step, DSM’s dry or liquid premixes can

be added to a vast range of food, beverage

and nutraceutical applications, providing

manufacturers with opportunities to tap

into the lucrative market for joint health

products. DSM’s nutritional solutions are

protected by the Quality for Life seal —

which ensures the ingredients come from a

dependable, safe and sustainable source —

giving manufacturers the confidence to go

to market with new products.

www.nutraceuticalmag.com January/February 2012

44weight management

During the past 20 years, there

has been a dramatic increase in

obesity and the incidence of being

overweight. Evidence suggests

that even without reaching an ideal weight,

a moderate amount of weight loss can be

beneficial in terms of reducing the levels of

some risk factors, such as blood pressure.1

SANKOM-CanDiet is a dietary supplement that

contains inulin and oligofructose enriched with

vitamins, mineral salts, green tea and natural

flavours. Inulin and oligofructose are dietary

fibres known as fructans. Inulin is a linear

fructose polymer belonging to the group of

fructans known for its fermentability and bulking

properties. Oligofructose, a short-chain fructan

obtained from inulin, might enhance satiety,

thereby resulting in greater reductions in energy

intake.2,3 Green tea, by containing both tea

catechins and caffeine, may act by inhibiting

catechol O-methyl-transferase, and by

inhibiting phosphodiesterase, providing positive

effects on body weight management.4

In an open pilot trial to evaluate body

weight reduction during a period of 4 weeks

using SANKOM-CanDiet supplement chews,

we selected 51 overweight patients (23 men

and 28 women), aged between 18 and 60

years. Patients suffering from obesity as a

result of hormonal or metabolic diseases

were not included in the trial. A daily dose of

4–6 SANKOM-CanDiet supplement chews

was recommended to each patient and the

duration of the programme was 4 weeks.

We gave each patient the following intake

recommendations:

• 1–2 chews + 1 glass of water (or warm tea)

30–40 minutes before lunch

• 1–2 chews + 1 glass of water (or warm tea)

in between lunch and dinner to prevent

hunger fluctuation

• 1–2 chews + 1 glass of water (or warm tea)

30–40 minutes before dinner.

No hypocaloric diet was suggested to

patients.

Summary of ResultsThe observational results of this trial show

a total average weight loss of 3.1 kg (an

average loss of 2.7 kg in women and 3.5 kg in

men). Considering four ranges of weight loss:

4 men and 8 women had a weight loss in the

0–2 kg range, 11 men and 6 women were in

the 2–4 kg range, 8 men and 6 women were

in the 4-6 kg range and 2 women were in the

6–8 kg range. One woman had a weight gain

of 0.1 kg and another woman experienced

a gain of 0.2 kg. No change in bodyweight

was observed in 1 man and 3 women.

Furthermore, we evaluated the Body Mass

Index in 25 randomly selected patients: at the

beginning of the trial the average BMI was

29.44, which had decreased to an average

BMI of 28.20 by the end of the trial.3

ConclusionsSANKOM-CanDiet was shown to be a

useful supplement in the management of

weight loss in overweight patients. This

open pilot trial presents a rationale to

propose oligofructose supplements for the

management of food intake in overweight

and obese patients. A double-blind

controlled study might be useful to better

evaluate the efficacy of SANKOM-CanDiet

supplement chews in weight reduction.

Furthermore, a normal calorie regimen

should be recommended and followed by

each patient, to reduce any eventual diet-

related interference.

INTuITIVE NuTrITION

References1. C.L. Ogden, et al., “The Epidemiology of Obesity,”

Gastroenterology 132(6), 2087–2102 (2007).2. P.D. Cani, et al., “Oligofructose Promotes Satiety

in Healthy Humans: A Pilot Study,” Eur. J. Clin. Nutr. 60, 567–572 (2006).

3. K. Whelan, et al., “Appetite During Consumption of Enteral Formula as a Sole Source of Nutrition: The Effect of Supplementing Pea-Fibre and Fructo-Oligosaccharides,” Br. J. Nutr. 96(2), 350–356 (2006).

4. M.S. Westerterp-Plantenga, “Green Tea Catechins, Caffeine and Body-Weight Regulation,” Physiol. Behav. 100(1), 42–46 (2010).

For more informationVladimir ShkolnikovSANKOM SwitzerlandAvenue de la Gare 49CH-2800 Delemont, SwitzerlandTel. +41 32 422 5000info@sankom.comwww.sankom.com

This open pilot trial presents a rationale to propose oligofructose supplements for the management of food intake in overweight and obese patients.

w w w . f o o d i n n o v a t e . c o m

City West Hotel, Dublin, Ireland

Researched and Produced

To register your place visit www.foodinnovate.com/NBT for only £1,795* when quoting “NBT” on the booking form. *This offer is only open to senior heads of food innovation, R&D, food technology and marketing from the food industry.

29th February – 1st March 2012

The 10th Annual World Food Technology and Innovation Forum gathers the world leaders in research and development, innovation and NPD to debate, and shape the future of the food industry

Key topics this year include-• Using Consumer Insights and Market Intelligence to Stimulate Innovation -

Optimising co-creation and innovation processes• Better Hunting Strategies - Building Open Innovation Opportunities -

Stimulating open innovation and accelerating better hunting to capture what’s outside and inside the organsition

• Successfully Taking New Ideas to Market - Understanding consumer trends and discovering new technologies that respond to consumer needs

• Combining Innovation With Sustainability - Engaging Procurement in the Innovation Process to achieve end-to-end sustainability

Who will be speaking?•Roger Leech, Open Innovation Portfolio & Scouting Director, Unilever •Richard Ebenbeck, Director - Consumer and Market Insights, Wrigley•Todd Eden, Head of Technical Innovation, Britvic Soft Drinks •Gerrit Smit, Vice President R&D, Valio•Kamel Chida, Associate Director Worldwide Innovation Network, General Mills

Host Sponsor

To find out more email Michaela Melcher, Michaela.melcher@wtgevents.com or call +44 (0)20 7202 7690

Confirm your place before

Christmas for only £1,795

www.foodinnovate.com/NBT

Quote “NBT”

www.nutraceuticalmag.com January/February 2012

46industry issues

A number of recent public recalls of

food products that have occurred

in the global consumer marketplace

have caused significant turbulence

in consumer confidence when it comes to

the safety of food and beverage products.

Any loss of confidence within the consumer

mindset is obviously a horrific situation for

a brand and the company that proffers the

product; consequences include millions of

wasted marketing dollars — plus millions

more reallocated to regaining confidence

— destruction of mindshare and grossly

impacted shareholder/ownership value. Most

importantly, the safety of people who trust a

brand enough to ingest it is, in many cases,

placed at serious risk.

Safely manufacturing products —

any products — within the food chain

has two prime points of contact: raw

material procurement and processing.

This short paper intends to provide an

overview for both.

T=0 (time begins at 0) begins at the

point of raw material procurement, but not

the actual purchasing of the material. The

primary point of failure in any supply chain is

the company’s cultural focus on “how they

buy;” a professionally managed organization

will have clear and concise specifications,

guidelines and processes to ensure that

there can be no misinterpretation by the

vendor, buyer or receiving organization.

Failure point number two occurs when the

buyer is rated and incentivized; show me

a purchase price incentivized buyer and I

will show you a buyer singularly focused

on price. Incentivize a buyer on the total

cost of quality, including being penalized

for rejections, and I will show you a buyer

who is motivated to find the highest quality

raw material at a market competitive price.

I always make the argument that no buyer

in a commodity market is so good that

they can negotiate a price more than 10%

below the market value. If you are receiving

a product significantly below this, then it’s

guaranteed that you are also receiving a

product below quality standards.

Once the procurement hygiene

is calibrated, the process of finding

specification compliant providers of raw

materials can begin. When one or more

is located, we find ourselves with the

opportunity for failure point three: the

qualification and continued surveillance of

an approved supplier. Taking a Suppliers

Certificate of Approval at face value only

makes the litigator’s job easy, stopping

by a supplier once a year for lunch or

a ceremonial dinner does not qualify

a supplier. It is imperative that your

procurement funds are buying a vendor’s

consistent process, internal safeguards

and market compensated professionals

who understand the deliverable that they

are providing. The deliverable must be a

specification compliant product harvested

or manufactured within accepted and

recognized agricultural or manufacturing

practices. Continued surveillance means

just that — continuous; a $2000 travel

expense is nickel slots compared with

a line down situation caused by a

product rejection at month or quarter’s

end. Garner your savings by operating

efficiently because you can schedule with

confidence, not by shortchanging your

quality focus.

Now that the raw material has arrived at

your dock, how squared away are you? The

media is replete with stories about government

inspected production facilities that were

grossly mismanaged, poorly run and downright

dangerous. The responsibility for safety is with

you, not an industry or governmental audit.

Once again, the company’s cultural focus goes

a long way to determine how professionally the

company is managed. Incentive programmes,

reviews and promotions must have a significant

quality hygiene component that rewards

(or is highly punitive) towards a professional

manager. Senior leadership cannot physically

be in every department, facility and supplier.

Nearly every case study of a recall begins

at a level far removed from the boardroom.

Despite this, we, as senior leaders, are totally

responsible for the actions of our colleagues and

the safety of our products and processes. How

one enforces and reinforces the standards of

professional conduct does much to protect your

business and ensure consumer safety.

wITHOuT A sAFETy NET

For more informationGeorge PontiakosPresident and CEOBI Nutraceuticalsgpontiakos@botanicals.comwww.botanicals.com

Inspiring innovations in ingredients

22 - 24 May 2012 | Palexpo | GENEVA PALEXPO | Switzerland

http://www.vitafoods.eu.com/nbt

Portfolio includesOrganised bySupported by

Asia

nutraceuticals l dietary supplements l functional food and drinks

• Source 1000s of innovative products• Keep up to date with the latest trends• Meet with over 500 leading suppliers• Network with peers from over 92

visiting countries• Finalise serious business deals

Register online now for FREE at

VF Europe Ads_nbt_210x279.indd 1 4/1/12 17:03:05

www.nutraceuticalmag.com January/February 2012

48pharma foods

An increased awareness of advances

in biotechnology has led to a growing

interest in the use of foods for medical

purposes, building on the long-standing

tradition in many cultures of using natural herbs

and foods to treat ailments. So-called ‘superfoods’

have been in receipt of increasing attention in

recent years, particularly from the media — this

interest is now rapidly expanding to foods with

clinically enhanced properties.

Probiotics, prebiotics, functional foods, clinical

foods and nutraceuticals are discussed and

promoted in terms of offering general health

benefits or specifically targeting a bodily function,

such as improving digestion, bone density

and so on. As technology evolves and more is

understood about how to tailor food and drug

combinations to better fit individual needs, the

opportunity for tailored food that uses improved

genetic profiling is burgeoning. Many in the

pharmaceutical and food industries predict that,

by 2020, biotechnical advances will allow us

regularly to combine foods grown in the field with

drugs developed in the lab; in the next decade,

we can expect to see a shift in some of our

basics from traditional ‘farmer foods’ to more

sophisticated ‘pharma foods.’

The term nutraceutical, a combination

of nutrition and pharmaceutical, is used

to describe food, or a part of a food, that

provides medical or health benefits, including

the prevention and/or treatment of a disease:

one person’s functional food can be another

person’s nutraceutical. Given that they are

cheaper than pharmaceutical products

and may provide some of the benefits, the

nutraceutical industry is an area of growth that

is now attracting pharmaceutical and biotech

companies; including the likes of Monsanto,

DuPont, Abbott, Johnson & Johnson, Novartis

and Genzyme Transgenic. Clinical — or medical

— foods are by contrast specifically formulated

to meet the particular nutritional requirements

of individuals with specific illnesses. They

are regulated and therefore prescribed by

physicians. Nutraceuticals therefore, are not

clinical foods.

These products have been entering the

market during recent years — but the greatest

potential now lies in foods created for medical

benefit. The big change is the link between

food preparation and nutrigenomics, which

refers to applying the sciences of genomics,

transcriptomics, proteomics and metabolomics

to human nutrition. Nutrigenomics is a

relatively new science and is the application

of highthroughput genomic tools to nutrition

research: now that human genes have been

sequenced and we understand more about

our genetic make-up, we can use the science

of nutrigenomics to tailor food to fit our genetic

profiles. Pharma foods, biopharmaceuticals

or ‘farmaceuticals,’ compounds produced

from genetically modified crops or animals,

are the result of this. They provide higher than

usual amounts of various nutrients that can be

consumed as foods but are distinguished from

functional foods, nutraceuticals and the like in

that they are not naturally occurring. They are

engineered to provide specific health benefits;

for instance, gene ‘pharming’ allows scientists

to alter an animal’s DNA by combining it with

DNA from another species. The resulting

genetically modified animals — transgenic fish,

cattle, sheep, goats and chickens — are tailored

to provide embedded drugs and proteins for

human consumption. Proponents, such as the

Biotechnology Industry Organization, see that

not only can transgenic animals be provided with

traits that will improve disease resistance, but that

they can also accelerate growth and increase

proteins, provider leaner meats, increased

muscle mass and improved nutritional quality.

So, for example, a salmon can be raised in half

the normal time, have less fat, more meat and

include extra nutrients. Although no products

of this kind are currently on the market, the

US National Academy of Science undertook

a study that did not identify any food safety

concerns. However, alongside the ethical issues

of blurring the differences between separate

species, issues around environmental impact

and animal welfare are raised by those who

oppose this type of development. Plant-made

pharmaceuticals are produced using similar

technology in plants: transgenic plants are

engineered to have resistance to pests and harsh

conditions in addition to improved shelf-life and

nutritional value. Modified potatoes have been

enhanced with protein and, in 2008, scientists

altered a carrot so that it would produce calcium

and become a possible cure for osteoporosis.

There has also been discussion of the benefits to

vitamin A deficiency offered by the consumption

of golden rice, which was developed by the

International Rice Research Institute to alleviate

micronutrient deficiencies in developing countries.

As a group, pharma foods of this kind have

been a controversial issue. For example, back

in 2007 several food companies lobbied the US

Department of Agriculture against the introduction

of pharma foods owing to “concerns about their

negative impacts on food safety, on markets for

food crops and on the integrity of the wider food

supply.” PepsiCo saw that “the significant risk of

crop contamination that is present when plant-

made pharmaceuticals are produced in food

and/or feed crops leads us to the conclusion that

the only way to prevent such a contamination is

to prohibit their production.” In its 2008 corporate

social responsibility report, which addressed

concern surrounding the testing of plant-made

pharmaceuticals, General Mills stated that “to

fully ensure the safety of world production via

plants and grains, General Mills currently opposes

moving to production of any so-called ‘pharma-

food’ that would use a food crop or food grain to

grow or produce plant-made pharmaceuticals.”

Despite this reticence, however, and given

the increasingly populous and hungry world,

many companies are now proceeding with

the development of pharma foods. In his initial

perspective on the future of food, Jim Kirkwood

highlighted the opportunities and challenges:

“Pharma-food, the intersection between food and

pharmaceuticals, is an area of growing opportunity

for many in the food sector. As consumers

demand more technologically sophisticated

foods with unique, complex health benefits,

food companies will need to respond. We now

understand more about individuals’ disease

propensities from the human genome. Therefore,

nutrigenomic determination of diet becomes

technically possible. Technology is advancing

and as natural bioactive components are better

understood, the line between pharma and food

will blur: the challenge will be to find new ways

to continue to provide natural, food-delivered

preventive health benefits and begin to provide

natural, food-delivered disease state improvement

benefits without food becoming a drug.”

In a New York workshop this view gained

clear support. Besides the wider recognition

of the global need for more proteins and

nutrients, participants perceived that “genetic

profiling is advancing very quickly and is now

accepted as a good thing,” “business models

in the pharmaceuticals sector are encouraging

significant investment in the area” and that

“nutrigenomics will fundamentally change

consumer healthcare, as nutritional screening

becomes a standard part of health check-ups

and consumers readily provide their genetic

profile.” Although a controversial subject,

given the benefits to be gained, the fast pace

of technology development and a shift in

government regulation on the horizon, the advent

of widespread availability of pharma foods by

2020 looks increasingly likely. Customized foods

that match medical benefit to your genetic profile

will be in your shopping basket soon.

FrOm FArmEr TO PHArmA

For more informationTim Jones and Caroline DewingInfinite Ideas Limited36 St GilesOxford OX1 3LDUK

This article was originally published in “Future Agenda: The World in 2020,” by Infinite Ideas Limited (www.infideas.com) and is reproduced with kind permission.

Many in the

pharmaceutical and

and food industries

predict that, by 2020,

biotechnical advances

will allow us regularly

to combine foods grown

in the field with drugs

developed in the labs

50regulatory review

There is nothing more frustrating than

being pressed for time to get an order

filled — all you are waiting for are the

analytical results to release a product …

only the results are nothing like what is expected.

It is important to evaluate how a given method

might affect the product by considering the

analyte being tested in addition to everything else:

the sample matrix. This is a simple task in relation

to multivitamins or other products for which every

compound is known. However, for botanical

extracts — which are very complex mixtures

that can contain hundreds of different chemical

compounds, the chemical structure of which may

be unknown— it poses major difficulties. Many of

the USP assay methods for a specific analyte are

designed for raw materials or a defined finished

product and will not perform effectively for a

finished product containing botanical extracts. A

simple physical analysis or colourimetric method

might be sufficient for a raw material because

there are no other components to interfere,

whereas one must assess all possible interfering

components with a finished product.

The general progression for testing an

analyte in a complex matrix involves sample

preparation/extraction, separation and

detection; each step must be considered

in relation to each product, even if only

one component is different. For example,

in a finished product tested for individual

bioflavanoids containing various fruit and

vegetable sources including grape seed extract,

the substitution of grape seed extract with green

tea extract could drastically affect

analytical results. For optimal method

selection, one must consider the

chemistry that occurs at each of

the phases of analysis, keeping

in mind that detector

results rely heavily on

the way in which the

sample is prepared.

Extractions are of two

main types: liquid-

liquid (also

known as

partitioning or solvent extraction) and solid-

liquid, including solid phase extraction (SPE)

and, more recently, solid phase micro

extraction (SPME). Liquid extractions are

based on the chemical concept of immiscibility

between two phases, as seen between oil and

water. An anlayte has more affinity to dissolve

with one or the other based on the chemistry

concept of “like dissolves like.” There are many

solvents available to the chemist, which possess

various properties that allow the removal of the

analyte from the matrix; properties to consider

are polarity, dipole moment and hydrogen

bonding capacity — sugars, for example, are

polar and as a result readily dissolve in polar

solvents such as water or alcohols. Super critical

fluid extraction is gaining in popularity as another

type of extraction technique, although the

cost of equipment prevents it from becoming

commonplace in most analytical laboratories.

The extraction fluid is neither a liquid nor a gas

but it maintains the transport properties of a

gas and the solvent-like characteristics of a

liquid, with the advantages of good analyte

selectivity, efficiency with repeat runs, suitability

with thermally labile compounds and low solvent

consumption. Only high throughput analysis can

justify using this type of extraction.

For solid-liquid phase extractions, ionic

and covalent interactions are also possibilities

to consider when attempting to remove an

analyte from the matrix. In the case of solid

samples, a liquid extraction must be performed

prior to solid-liquid phase extractions as liquid

containing the analyte must pass over the solid

support. This support provides a surface for

chemical interactions to occur between the

solid and the different compounds in solution.

The solid can be used to selectively bind

the analyte or bind unwanted compounds;

either way, it is a method for trying to isolate

the analyte being tested. Once the analyte or

unwanted compounds bind to the solid support,

the first solvent is removed and a second is

added to break the bond formed between

the solid and the analyte, which leaves the

compound dissolved in the new solvent. The

second solvent must have a higher affinity for

the compound than the solid support — if the

analyte of interest has no affinity for the solid,

it will simply remain in the first solvent while

many of the unwanted compounds stay bound

to the solid support. Both processes help to

clarify the mixture and make the next steps of

separation and detection easier. SPE can also

be used to concentrate the analyte in cases

where it is present at very low concentrations

(such as vitamin B12 in liquid products).

SPE solid supports include reverse phase,

normal phase, ion exchange and adsorption.

However, it is constantly evolving and some

of the new technologies, including molecularly

imprinted polymers (MIPs), are selective for

a single analyte or a group of structurally

related analytes, thus reducing the amount of

nonspecific binding of unwanted compounds.

Once the anlayte is drawn out of the matrix

and into a suitable solvent, the next step is

to separate it from other compounds also

extracted into the solvent, using a highly

controlled and repeatable process with

sophisticated chromatographic instrumentation

and identify/quantitate it with technologically

advanced detectors. The ultimate goal is to

make preparation simple with as few steps

as possible, which reduces human error.

Nevertheless, the reality is that extraction and

sample preparation are limited by the structure

of the compounds in the matrix and complex

samples will likely mean complex preparation.

FINDING THE NEEDLE IN THE HAysTACk

For more informationDr Cheri TurmanDirector of ChemistryAnalytical Food Laboratories Tel. +1 800 242 6494cheri@afltexas.com

Dr Cheri Turman

www.nutraceuticalmag.com January/February 2012

January/February 2012 www.nutraceuticalmag.com

ARTINIA® is a registered trademark of Novus Nutrition Brands, LLC. © 2011.

ARTINIA® supports healthy arteries.The heart needs clean, healthy arteries to function at its best.

ARTINIA is an innovative fiber that supports the body’s natural defenses against

oxidized-LDL cholesterol. This all-natural, GRAS, EU Commission Approved novel food

ingredient is gluten-free, Kosher, non-GMO and hypoallergenic.

Give your next heart health product an arterial advantage. Choose ARTINIA.

Healthy arteries support a healthy heart.

To learn more about ARTINIA visit www.stratumnutrition.com

C

M

Y

CM

MY

CY

CMY

K

new_artinia_NBT_rev.pdf 1 12/20/11 3:07 PM

www.nutraceuticalmag.com January/February 2012