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Are Non-Nutritive Sweeteners Safe? A Look at the Evidence March 26, 2011 Houston, TX

Are Non-Nutritive Sweeteners Safe? A Look at the … Files/Syllabus Files...Session 6: Are Non-Nutritive Sweeteners Safe? A Look at the Evidence? Learning Objectives 1. Outline the

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Are Non-Nutritive Sweeteners Safe? A Look at the Evidence

March 26, 2011

Houston, TX

Session 6: Are Non-Nutritive Sweeteners Safe? A Look at the Evidence? Learning Objectives

1. Outline the current evidence regarding the safety of non-nutritive sweeteners 2. Educate patients regarding the potentials benefits and risks of ingesting foods and beverages sweetened with

sugar substitutes Faculty

Judith Wylie-Rosett, EdD, RD

Session 6

Professor and Division Head for Behavioral and Nutritional Research Department of Epidemiology and Population Health Albert Einstein College of Medicine Bronx, New York

Judith Wylie-Rosett, EdD, RD, is professor of epidemiology and population health and head of the Division of Behavioral and Nutritional Research at Albert Einstein College of Medicine. Dr Wylie-Rosett has served as an investigator in the Diabetes Control and Complications Trial, the Diabetes Prevention Program, the Women’s Health Initiative, and the Trial of Antihypertensive Interventions and Management Study. Her own National Institutes of Health–funded research has addressed resource utilization in weight control. Dr Wylie-Rosett is also associate editor of the journal Diabetes Care. Her publications include over 140 peer-reviewed research papers, over 50 review and practice-based papers, 30 book chapters and four books. Faculty Financial Disclosure Statement The presenting faculty reported the following: Judith Wylie-Rosett, EdD, RD receives grant/research support as an investigator for Kraft and receives honoraria from Unilever and Monsanto as a consultant. Education Partner Financial Disclosure Statement The content collaborators at American Society of Nutrition have reported the following: Richard Kahn, PhD does not have anything to disclose. FDA-Approved Non-Nutritive Sweetener List Sweetener Trade Name(s) acesulfame-K Sweet One, Sunnett aspartame NutraSweet, Equal

neotame In products in combination with NutraSweet

stevia Truvia, PureVia, Sweet Leaf saccharin Sweet ‘N Low sucralose Splenda

Session 6

Acronym List Acronym Definition ADI acceptable daily intake GRAS generally recognized as safe Suggested Reading List Anton SD, Martin CK, Han H, et al. Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. Appetite. 2010;55(1):37-43. Bellisle F, Drewnowski A. Intense sweeteners, energy intake and the control of body weight. Eur J Clin Nutr. 2007;61(6):691-700. Brown RJ, Banate MA, Rother KI. Artificial sweeteners: A systemic review of metabolic effects in youth. Int J Pediatr Obes. 2010;5(4)305-312). Kroger M, Meister K, Kava R. Low-calorie sweeteners and other sugars substitutes: a review of the safety issues. Comprehensive Reviews in Food Science and Safety. 2006;5:35-47. Mattes RD, Popkin BM. Nonnutritive sweetener consumption in humans: effects on appetite and food intake and their putative mechanisms. Am J Clin Nutr 2009;89 (1):1-14.

National Cancer Institute. Fact Sheet Artificial sweeteners and cancer. http://www.cancer.gov/cancertopics/factsheet/Risk/artificial-sweeteners. Accessed Feb 23, 2011. Suddath C. Are artificial sweeteners really that bad for you? Time May 20, 2009. http://www.time.com/time/health/article/0,8599,1931116,00.html. Accessed Feb 23, 2011. Swithers SE, Martin AA, Davidson TL. High-intensity sweeteners and energy balance. Physiol Behav. 2010;100(1):55-62. Yang Q. Gain weight by “going diet?” Artificial sweeteners and the neurobiology of sugar cravings. Yale J Biol Med. 2010;83(2):101-108.

1

Judith Wylie-Rosett, EdD, RD

Albert Einstein College of Medicine

Bronx, NY

Are Non-Nutritive Sweeteners Safe?A Look at the Evidence

Food, Nutrition and Health: Controversies and Clinical Solutions

DisclosuresDr. Wylie-Rosett receives grant/research support as an Investigator for Kraft and receives honoraria from Unilever and Monsanto as a Consultant.

Pre-Test Question 1

1. Extremely confident

2. Very confident

3. Moderately confident

4. Slightly confident

5. Not confident at all

?

How confident would you be discussing the benefits and downfalls of non‐nutritive sweeteners (NNS)?

1. Increased diet soda consumption was associated with an increase in the incidence of bladder cancer.

2. Increased consumption was largely accounted for by the increased intake of NNS from diet soda among adolescents.

3. Increased consumption of NNS was less, per capita, than the increased intake of  nutritive sweeteners. 

4. Increased consumption was accounted for by an increase in advertizing dollars  for diet soda. 

?Pre-Test Question 2

Which of the following statements is accurate with regard to the increased consumption of NNS from 1965 to 2004? 

1) Headaches and seizures occur in individuals who exceed the acceptable daily limit.

2) Aspartame should NOT be consumed by individuals without the enzyme to metabolize phenylalanine.

3) Aspartame can raise methanol  levels enough to  impair judgment.

4) Aspartame increases requirements for vitamin B12.

?Pre-Test Question 3

In accordance with FDA warnings, which of the following would you warn patients about with regard to the safety of aspartame? 

1) The incidence of diabetes and metabolic syndrome is higher in daily diet  soda consumers.

2) Report that  higher intake of non‐nutritive sweeteners intake is associated with higher risk of brain tumors.

3) Results from these studies are used to establish the acceptable intake (ADI).

4) Results from these studies provide evidence that is used to classify a non‐nutritive sweetener on the generally recognized as safe (GRAS) list. 

Pre-Test Question 4 ?

Longitudinal  data from multicenter studies suggest which of the following?

2

Issues

1. Intake trends for non-nutritive sweeteners (NNS)

2. Food & Drug Administration (FDA) procedures to establish the acceptable daily intake (ADI)

3. Examination of chemistry and safety of NNS

4. Evidence review of potential benefits

How Does Perception of Terms Vary?

Artificial sweeteners

Sugar substitutes

Non-nutritive sweeteners

Low-calorie sweeteners

High-intensity sweeteners

Issues

1. Intake trends for non-nutritive sweeteners (NNS)

2.2. Food & Drug Administration (FDA) Food & Drug Administration (FDA) procedures to establish the acceptable daily procedures to establish the acceptable daily intake (ADI)intake (ADI)

3.3. Examination of chemistry and safety of NNSExamination of chemistry and safety of NNS

4.4. Evidence review of potential benefitsEvidence review of potential benefits

Consuming Beverage: % of Population

Mattes RD, et al. Am J Clin Nutr. 2009;89 (1):1-14.

Trends in Per Capita IntakeGrams of Foods and Beverages

Year

Mattes RD, et al. Am J Clin Nutr. 2009;89(1):1-14.

International Food and Nutrition Council (IFIC)2010 Consumer Survey

N = 1024

40-45% tried to avoid products containing non-nutritive sweeteners

41% tried to avoid refined carbohydrates

70% tried to avoid sugar

22% of those trying to lose/maintain weight (n=788) used non-nutritive sweeteners as strategy

2010 Food & Health Survey: Consumer Attitudes Toward Food Safety, Nutrition & Health. International Food Information Council Foundation Website. http://www.foodinsight.org/Resources/Detail.aspx?topic=2010_Food_and_Health_Survey_Media_Resources.

3

Sources of Beverage Intake of Adults24-Hour Recall Snapshot

National Health and Nutrition Survey (NHANES) 2005-2006

Sources of Beverage Intake of Adults. National Cancer Institute (NCI) Web site. http://riskfactor.cancer.gov/diet/foodsources/beverages/figure7.html

Beverage Intake of Children: Age 2-18 Years24-Hour Recall Snapshot

National Health and Nutrition Survey (NHANES) 2005-2006

Sources of Beverage Intake of Children. National Cancer Institute (NCI) Web site. http://riskfactor.cancer.gov/diet/foodsources/beverages/figure3.html

Issues 1.1. Intake trends for nonIntake trends for non--nutritive sweeteners (NNS)nutritive sweeteners (NNS)

2. Food & Drug Administration (FDA) procedures to establish the acceptable daily intake (ADI)

3.3. Examination of chemistry and safety of NNSExamination of chemistry and safety of NNS

FDA approved NNSFDA approved NNS

Other NNSOther NNS

4.4. Evidence review of potential benefitsEvidence review of potential benefits

The FDA methods for determining the acceptable daily intake include: 1) Testing for toxicity with non-rodents for 1 year.

2) Using national food consumption data to develop prediction models for adverse effects.

3) Human clinical trials conducted by the federal government labs.

4) Surveillance data derived from case reports of adverse effects to the Centers for Disease Control.

?

How is the sweetener made?

What are its properties when it is added to foods or beverages?

How much of the sweetener will be digested or otherwise absorbed by the body?

Are certain groups of people likely to be more susceptible than others to the additive?

Does the sweetener have any known toxic effects, including hereditary disorders or cancer?

Evaluation of Intensive Sweeteners as Food Additives. US Food and Drug Administration website http://www.cfsan.fda.gov/guidance.html

FDA Questions to Evaluate New Sweeteners as Food Additives: 1906 -Food & Drug Administration (FDA) established

1910 - Court Decision permitted addition of harmless non-nutritive ingredients up to .004 of the product

1938 to 1963 – Litigation over labeling and use of non-nutritive sweeteners in candy bars

1966 – Congress required non-nutritive substances have some practical function (FDA prohibited non-nutritive sweeteners)

1992 – FDA reinterpreted the 1966 law to allow non-nutritive sweeteners if generally recognized as safe (GRAS)

FDA Compliance Policy Guide Sec. 515.100 Confectionery

Use of Non-Nutritive Ingredients in Candy

FDA Compliance Policy Guide Sec. 515.100 Confectionery . FDA Web site. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074512.htm

4

How does the FDA determine 100-fold safety level for the ADI for intense sweeteners?

Genetic toxicityShort-term testsLonger term reproduction studies

Potential damage to reproductive systemPotential birth defects

Metabolic and pharmacokinetic studies

Sub-chronic toxicityShort term tests (usually 90 days in rodents)One year testing in non-rodents

• Chronic (lifetime duration i.e., 24 months, typically) studies of toxicity and carcinogenicity in rodents

Rulis AM, et al. Regul Toxicol Pharmacol. 2009;53 (1):20-31.

Issues 1.1. Intake trends for nonIntake trends for non--nutritive sweeteners nutritive sweeteners

(NNS)(NNS)

2.2. Food & Drug Administration (FDA) Food & Drug Administration (FDA) procedures to establish the acceptable procedures to establish the acceptable daily intake (ADI)daily intake (ADI)

3. Examination of chemistry and safety of NNS

4.4. Evidence review of potential benefitsEvidence review of potential benefits

Saccharin

300 times as sweet as sucroseDiscovered in 1879 Increased usage during WWII sugar shortageUsed in soft drinks, table top sweeteners and foods Has a slightly bitter aftertaste Is heat stable

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Saccharin: Safety Considerations

Rat research found increased risk of bladder cancer rates with intake cyclamate and saccharin.Saccharin was banned by FDA in 1970 with subsequent congressional intervention that put it back on the market.The FDA require a cancer warning label from 1972-2000.The ADI established by the FDA is 5mg/kg.*The FDA permits 2 mg per fluid ounce in beverages.

* same as WHO and Europe ADI

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Aspartame

Aspartame is 200 times sweeter than sucrose.

Aspartame is a methyl ester dipeptide of phenylalanine and aspartic acid.

Aspartame is digested as a protein, and amino acids are metabolized.

Aspartame is not stable when heated/not used in cooking.

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Aspartame –Safety Considerations

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

5

Neotame

8,000-13,00 times as sweet as sucroseSimilar structure to aspartame but dimethylbutylgroup prevent enzymatic breakdownIs used in combination with other sweeteners in food products

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

NeotameDiscovered 1965 and FDA approval in 2002Hydrolyzed to produce methanol but less than found in fruit juiceADI is set by FDA at 18 mg/kg*Is not subject to enzymatic breakdown to amino acids and is excreted unchanged

* WHO and Europe ADI 1-2 mg/kg

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Acesulfame potassium or Acesulfame-K

200 times as sweet as sucroseDiscovered 1967 and FDA approval 1988Heat stable

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Acesulfame-K: Safety Considerations

Discovered in 1967 and approved by FDA in 1988Questions about breast tumors in lab animalsADI is set by FDA at 15mg/kg*Approved by FDA for general use except for in meat and poultry

* World Health Organization and Europe ADI 9-40mmg/kg

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Sucralose

600 times sweeter than sucroseMade from sucrose by replacing 3 hydroxyl groups (OH) with chloride (Cl) Stable at hot and cold temperatures

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Sucralose – Safety ConsiderationDiscovered in 1976 and FDA approved in 1998Extensive animal testingExcreted from the body unchanged in short-term and long term studiesOne Danish study of premature birthsADI is set by FDA at 5 mg/kg*

* WHO and Europe ADI are 15 mg/kg

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

6

Stevia(rebiana)

Up to 300 times as sweet as sucrose

Stevia plant leaves were widely used for centuries in South America to sweeten foods and beverages

Stevioside and rebaudioside -sweet steviolglycosides extracted from the stevia leaf.

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

Stevia: Safety Considerations

Used as non-nutritive sweetener in Japan since 1970 and considered a natural sweetener.

Was available used as herbal supplement/sweetener before FDA approval in 2008

Controversy surrounding stevia FDA review (? had limited patent potential)

Some calls for more safety testing

ADI is set by FDA at 12 mg/kg

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute; Non-Nutritive Sweeteners Evidence Analysis Project. .American Dietetic Association Web Site. http://www.adaevidencelibrary.com/topic.cfm?cat=2797&auth=1

United States Versus Canada

Food and Drug AdministrationThe six FDA approved non-nutritive sweeteners (Acesulfame-K, Asparatame,Neotame,Saccharin, Stevia and Sucralose).

VERSUS Health Canada

• Asparatame, Neotame, Sucralose approved for adding to foods.

• Saccharin, Stevia and Cyclamates are approved ONLY for table top use.

Sugar Substitutes. Health Canada Web site. http://www.hc-sc.gc.ca/fn-an/securit/addit/sweeten-edulcor/index-eng.php

In general, it's best to avoid the following ingredients.

Sodium nitrite

Saccharin, Aspartame, Acesulfame-K

Caffeine

Olestra

Food dyes

And don't forget to cut back on sugar and salt, which cause more harm than all the other additives combined.

Chemical Cuisine: Learn about Food Additives. Center for Science in the Public Interest Web site.http://www.cspinet.org/reports/chemcuisine.htm

Other Reduced Calorie and Calorie- Free Sweeteners

Thaumatin

Protein (207 amino acids) produced as a natural response by the blossoms and fruit of tropical flowering plant (katemfe) in response to viroid exposure2000 times sweeter than sucrose Perception of sweetness builds very slowly.Leaves liquorice like after-taste at high usage levelshighly water-soluble, stable to heating, and stable under acidic conditionsApproved as a sweetener in European Union, Japan, and Israel GRAS classification by FDA as flavoring not sweetener

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute .Thaumatin Fact Sheet. International Sweetener Organization Web Site.http://www.sweeteners.org/pdf/Thaumatin_November_2009_EN.pdf

7

Sweetener --Supplement not NNS• Contains 5 calories per packet

• Ingredients: Inulin, fructose, natural flavors, probiotics (bacillus coagualans) vitamins and minerals

Blends of ingredients approved by FDA

Nutritionals retains TransMedia for brand promotion. Food Business Review Web Site. http://ingredients.food-business-review.com/news/nxt-nutritionals-retains-transmedia-for-brand-promotion-110111#

Table Top Sweetener

Labeled as calorie free (< 5 calorie/serving)

Ingredients:Xylitol, Maltodextrin and less than 0.3% Sucralose for added sweetness.

Polyols (Sugar Alcohols)Calories Per Gram

3.0 calories/gram hydrogenated starch hydrolysates

2.6 calorie/gram sorbitol

2.4 calories/gram xylitol

2.1 calories/gram maltitol

2.0 calories/gram isomalt

2.0 calories/ gram lactitol

1.6 calories/gram mannitol

0.2 calories/gram erythritol

Polyol Information Source. Polyol Organization Web site. http://www.polyol.org/fap/fap_q_and_a.html

Sugar Alcohols (Polyols)Used in ice creams, cookies, puddings, candies & gum

• Occur as natural plant products and extractions are used as foodadditives

• Gas and diarrhea via fermentation of carbohydrate not absorbed in small intestines.

• May be labeled as sugar free or no added sugar

May be labeled as reduced calorie if 25% lower if with sugar

Not as sweet as sugars (may be combined with non-nutritive sweetener)

Generally Recognized as Safe (GRAS)

American Diabetes Association @ http://www.diabetes.org/food-and-fitness/food/what-can-i-eat/sugar-alcohols.htmland Yale New Haven Hospital @ http://www.ynhh.org/about-

us/sugar_alcohol.aspx

Sweeteners WithoutFDA Approval

Cyclamate BANNED BY FDA IN 1970

30-50 times as sweet as sucrose.

Sodium or calcium salt of cyclamic acid

Large doses caused bladder cancer in rats.

Still used as a sweetener in 55 countries.

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute

8

Brazzein(potential FDA application)

Protein extracted from Oubli, the fruit of a West African vine (Pentadiplandra brazzeana Baillon).

1000 times as sweet as sucrose

Will be produced from genetically modified corn because large scale extraction is not feasible.

Sugar Substitutes .Wikipedia Web Site. http://en.wikipedia.org/wiki/Sugar_substitute

Issues

1.1. Intake trends for nonIntake trends for non--nutritive sweeteners nutritive sweeteners (NNS)(NNS)

2.2. Food & Drug Administration (FDA) procedures Food & Drug Administration (FDA) procedures to establish the acceptable daily intake (ADI)to establish the acceptable daily intake (ADI)

3.3. Examination of chemistry and safety of NNSExamination of chemistry and safety of NNS

4. Evidence review of potential benefits

Double Blind Randomized TrialDiet VS. Sugar Sweetened Beverages

Adolescents n = 103

All drank > 12 oz sugar sweetened beverages before study

Received home beverage delivery

25 week intervention

Intervention goal intake of two 12 ounce beverages per day (diet vs. sugared)

Ebbling CB,et al. Pediatrics 2006;117 (3) :673-680.

Diet

Sugared

Difference if BMI > 30

Dietary Intake and Incidence of Metabolic Syndrome Hazard Ratio over 9 Years follow-up by Intake Tertile

Atherosclerosis Risk in Communities (ARIC) StudyTertile 1 2 3 P

Lutsey PL, et al. Circulation 2008;117:754-61

Model 1 was adjusted for age, sex, race, education, center, and total calories.

Model 2 was adjusted for Model 1 plus smoking status, physical activity, and intake of meat, dairy, fruit and vegetables, whole grains and refined grains.

Multiethnic Study of Atherosclerosis (MESA) Baseline Data

Intake of Diet Soft Drinks -Key differences P<.001

Nettleton JA, et al. Diabetes Care 2009; 32 (4):688-694

IntakeN =

Never2961

< 1/wk455

1/wk - < 1/day914

1/day681

Servings/day 0 0.1 0.4 2.5

BMI (kg/m2) 27.3 28.3 28.5 29.3

Kcal/day 1,673 1,608 1,631 1,871

Waist (cm) 95.6 97.2 98.3 100.6

Activity MET min/wk 2,357 2,745 2,746 2,670

High school degree 80.3% 91.2% 92.5% 88.5%

White 34% 46.6% 58.6% 62.1%

African American 27.0% 23.7% 15.4% 17.8%

Hispanic 22.7% 18.0% 21.1% 15.3%

Chinese 16.3% 11.7% 4.8% 4.9%

Incident Metabolic Syndrome: 5 -7 Year s Follow-UpMultiethnic Study of Atherosclerosis (MESA)

Nettleton JA, et al. Diabetes Care 2009; 32 (4):688-694 HR- Hazards RatioCI - Confidence Interval

Baseline Diet Soda(Frequency of servings)

Rare or Never

< 1/Wk 1-6/Wk > 1/Day Ptrend

NCases

2,288478

36795

772169

501129

HR(95% CI)Model 1*

1.00 1.34(1.07-1.67)

1.20(1.00-1.43)

1.31(1.07-1.60)

.003

Model 2 : Adjust Mod 1 + educ, activity, smoking, supplements

1.00 1.42(114-178)

1.28(1.06-1.53)

1.36)(1.11-1.66)

<.001

Model 3: Adjust Mod 2 +waist circumference

1.00 1.31(1.05-1.67)

1.13(0.94-1.37)

1.18(0.96-1.44)

.06

Model 4: Adjust Mod 3 +BMI

1.00 1.30(1.04-1.62)

1.15(0.95-1.38)

1.17(0.94-1.44)

.06

Model (mod) 1 adjust for site, age, sex, race/ethnicity & energy intake.

9

Incident Diabetes: 5 -7 Year s Follow-UpMultiethnic Study of Atherosclerosis (MESA)

Nettleton JA, et al. Diabetes Care 2009; 32 (4):688-694 HR- Hazards RatioCI - Confidence Interval

Baseline Diet Soda(Frequency of servings)

Rare or Never

< 1/Wk 1-6/Wk > 1/Day Ptrend

NCases

2,961221

45533

91484

98175

HR(95% CI)Model 1*

1.00 1.06(0.73-1.52)

1.39(1.07-1.80)

1.63(1.24-2.13)

<.001

Model 2 : Adjust Mod 1 + educ, activity, smoking, supplements

1.0 1.10(0.76-1.59)

1.46(1.12-1.89)

1.67(1.27-2.20)

<.001

Model 3: Adjust Mod 2 +waist circumference

1.00 1.000.69-1.45)

1.23(0.94-1.60)

1.40(1.06-1.84)

.01

Model 4: Adjust Mod 3 +BMI

1.00 0.98(0.68-1.42)

1.25(0.96-1.62

1.38(1.04-1.820

.001

Model (mod) 1 adjust for site, age, sex, race/ethnicity & energy intake.

Weight reduction concerns

Based on Pavlovian conditioning principles, consumption of non-nutritive sweeteners could result in dissociation between the sweet taste cues and the caloric consequences could lead to a decrease in the ability of sweet tastes to evoke physiological responses that serve to regulate energy balance.

Swithers SE, et al. Physiol Behav 2010;100:55-62

Meal Study Evidence---NNS Pre-LoadLean and Obese Participants

When consuming stevia and aspartame preloads, participants did not compensate by eating more at either their lunch or dinner meal and reported similar levels of satiety compared to when they consumed the higher calorie sucrose preload.

Anton SD, et al. Appetite 2010;55 (1):37-43

Systematic Review EvidenceMetabolic Effects of Non-Nutritive Sweeteners in Youth

Randomized trials in children very limited.

Lack evidence of either beneficial or adverse effects of non-nutritive sweeteners on metabolic health parameters in children.

Brown RJ, et al. Int J Pediatr Obes 2010;5 (4):305-312.

Practical But Difficult Questions

Does reducing energy density of sweet beverages and foods have a measurable impact on appetite and energy intakes, as examined both in short-term studies and over a longer period? Can reductions in dietary energy density achieved with intense sweeteners really affect body weight control?

Bellisle F, et al. Eur J Clin Nutr 2007;61(6):691-700.

SummaryMost non-nutritive sweeteners are consumed in beverages

Intake of non-nutritive sweeteners has increased but not as much as sugar sweetened products

FDA has approved six non-nutritive sweeteners for general use

Caution for individuals with phenylketonuria who are missing the enzyme to break down phenylalanine

Epidemiological studies have shown higher intake of non-nutritive sweeteners is associated with higher body mass intake, diabetes and metabolic syndrome

10

ConclusionsUsing non-nutritive sweetened beverages as a

weight loss strategy needs to be within the context of an overall weight reduction plan.Acceptable Daily Intake provides guidance regarding safe usage but is difficult to quantify since the amount of non-nutritive sweeteners in products is not labeled.Collaborative counseling approaches can help address patient concerns and goals with respect to using non-nutritive sweeteners

Post-Test Question 1

1. Extremely confident

2. Very confident

3. Moderately confident

4. Slightly confident

5. Not confident at all

?

How confident would you be discussing the benefits and downfalls of non‐nutritive sweeteners (NNS)?

1. Increased diet soda consumption was associated with an increase in the incidence of bladder cancer.

2. Increased consumption was largely accounted for by the increased intake of NNS from diet soda among adolescents.

3. Increased consumption of NNS was less, per capita, than the increased intake of  nutritive sweeteners. 

4. Increased consumption was accounted for by an increase in advertizing dollars  for diet soda. 

?Post-Test Question 2

Which of the following statements is accurate with regard to the increased consumption of NNS from 1965 to 2004? 

1) Headaches and seizures occur in individuals who exceed the acceptable daily limit.

2) Aspartame should NOT be consumed by individuals without the enzyme to metabolize phenylalanine.

3) Aspartame can raise methanol  levels enough to  impair judgment.

4) Aspartame increases requirements for vitamin B12.

?Post-Test Question 3

In accordance with FDA warnings, which of the following would you warn patients about with regard to the safety of aspartame? 

1) The incidence of diabetes and metabolic syndrome is higher in daily diet  soda consumers.

2) Report that  higher intake of non‐nutritive sweeteners intake is associated with higher risk of brain tumors.

3) Results from these studies are used to establish the acceptable intake (ADI).

4) Results from these studies provide evidence that is used to classify a non‐nutritive sweetener on the generally recognized as safe (GRAS) list. 

Post-Test Question 4 ?

Longitudinal  data from multicenter studies suggest which of the following? Thank You!

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