Presentación de PowerPoint · Dyslipidemia : 50% in adult population have raised cholesterol Prediabetes : 35% in adult population ®Frutarom – Nov 17 Cardiovascular Health Phytochemicals

®Frutarom – Nov 17

NATURAL INGREDIENTS TO SUPPORT HEART HEALTH a focus on Mediterranean

botanical extracts Yannick Capelle – Product Manager Frutarom Health


Cardiovascular Health Risk factors

2

Health conditions with high prevalence

For example in England:

Hypertension : 1 in 3 adults have high blood pressure

Dyslipidemia : 50% in adult population have raised cholesterol

Prediabetes : 35% in adult population


Cardiovascular Health Phytochemicals from Mediterranean plants

3

Anthocyanins Transreveratrol

Oleuropein Hydroxytyrosol

Naringin

Neohesperidin

Alliin


Cardiovascular Health Health claims examples in DS & OTC

4

“Red vine leaf contributes to a good blood flow in the legs”

Art 13.1 on hold

“Herbal medicinal product for treatment of chronic venous

insufficiency, which is characterized by swollen legs, varicose

veins, a feeling of heaviness, pain, tiredness, itching, tension

and cramps in the calves.”

Well-established use

4


Cardiovascular Health Health claims examples in functional foods

5

Maintaining heart health is one of the top reasons

why consumers aged 55+ use functional foods

Limitations : health claims regulation regarding

cardiovascular health

Only 1% of new products make a cardiovascular

health claim

(Mintel report , April 2017)

®Frutarom – Nov 17 ®Frutarom – Nov 17


Multicomponent system, develops its activity profile

by synergic effects of its

components

Produced using

EFLA®HyperPure technology:

Solubility, stability,

purity

Efficacy and safety confirmed by

proprietary studies

Extract

form

Powder

Recommended

dosage

500-1000 mg/day

Standardization

Oleuropein (16-24%) Polyphenols (≥ 30%)

Characteristics

7


Tradition

Mediterranean region:

Against hypertension, diabetes, atherosclerosis

Against rheumatism, fever

As part of daily diet: spices and infusion

Olive leaf : traditional remedy

& supplement

8


Activity

Healthy

cholesterol

level

Healthy

blood sugar

level

Beneficial blood

pressure range

Coronary & vascular

protection (antioxidant)

9


Mode of action

Appropriate olive leaf preparations may combine at least two mechanisms:

Blood pressure

2. Angiotensin converting enzyme (ACE) inhibition 1. Increased Nitric Oxide (NO) production

10


Oral treatment with L-

NAME (nitro-L-arginine

methyl ester) induced

hypertension

8 weeks L-NAME + Benolea ® (prophylactic effect)

6 weeks, then concomitant Benolea ® administration for

a further 6 weeks (therapeutic effect)

Benolea® has prophylactic effect in preventing the

increase of blood pressure

Benolea® is capable of reducing established

hypertension

Excellent tolerance

In-vivo Study

11

Khayyal MT et al. (2002). Arzneimittelforschung 52 (11)

Efficacy of Benolea® to reduce blood pressure


Prophylactic

antihypertensive

effect of Benolea®

90

110

130

150

170

190

210

0 1 2 3 4 5 6 7 8

Blo

od

pre

ssu

re in

mm

Hg

week

L-NAME

L-NAME +

Benolea®

100 mg/kg BW

Control

Start of Benolea®

In-vivo Study

12


Prophylatic effect of Benolea®


Antihypertensive

action for therapeutic

effect

90

110

130

150

170

190

210

1 2 3 4 5 6 7 8 9 10 11 12

Blo

od

pre

ssu

re in

mm

Hg

week

L-NAME

L-NAME +

Benolea®

100 mg/kg BW

Control

Start of Benolea®

In-vivo Study

13


Therapeutic effect of Benolea®

®Frutarom – Nov 17 14

Effective, safe &

well tolerated

Herbal extract with clinically proven blood-pressure lowering

activity

German trial involving 20 monozygotic twin pairs with borderline

hypertension*:

8 weeks

500-1000 mg Benolea® / day vs. control group (no treatment)

significant antihypertensive effect

significant lowering of LDL-Cholesterol

excellent tolerance

Clinical Study 1 Efficacy of Benolea® to reduce blood pressure and LDL cholesterol

Perrinjaquet-Moccetti T et al, Phytotherapy Research 2008 vol 22 (9)


Dosage-grouping analysis

20 twin pairs

10 twin pairs

Group 1 10 twin pairs

Group 2

twin 1 0 mg

twin 2 500 mg

twin 1 500 mg

twin 2 1000 mg

Difference Difference

15


Clinical Study 1 Protocol


Significant blood

pressure lowering effect

of Benolea®

* Statistically significant within pairs difference, p < 0.05

6 mmHg

13 mmHg

5 mm Hg 5 mm Hg

16


Clinical Study 1 Efficacy of Benolea® to reduce blood pressure


Significant cholesterol

lowering effect D

iffe

ren

ce

fo

rm s

tart

va

lue

(m

mo

l/1) 0,0

-0,1

-0,2

-0,3

-0.4

-0,5

-0,6

Control vs. 500 mg. Benolea®/day

500 mg. Vs. 1000 mg Benolea®/day

(*statistically significant difference

p < 0.05)

After 4 weeks

Effects of Benolea® on mean LDL cholesterol, after 4 and 8 weeks.

Data represent mean differences within twin pair groups.

*

*

After 8 weeks

17


Clinical Study 1 Efficacy of Benolea® to reduce LDL cholesterol


Participants: 232 volunteers with stage-1 hypertension

(SBP 140-159 mmHg; DBP

90-99 mmHg)

Active-controlled:

116 on Benolea

116 on Captopril

Randomized, double-blind,

double-dummy design

Benolea Group Captopril Group

B P P C C

B

P

Benolea

Captopril

Placebo

18

Susalit E et al, Phytomedicine 2011 vol 18

Clinical Study 2 Protocol

2 x 500mg Benolea/day 2 x 12.5 mg Captopril/day


Blood pressure-reducing

effect of Benolea® is

similar to Captopril

0

- 2

- 4

- 6

- 8

- 10

- 12

- 14

- 16

1 2 3 4 5 6 7 8

Benolea®

Captopril

(*p < 0.05)

*

*

Duration of treatment (weeks)

Ch

an

ge

fro

m b

ase

line

(m

mH

g)

19


Clinical Study 2 Efficacy of Benolea® to reduce blood pressure


Blood lipid-lowering

effect of Benolea®,

compared to

Captopril

Ch

an

ge

fro

m b

ase

line

(m

g/d

l)

0

-4

-8

-12

4 8

Benolea®

Captopril Duration of treatment (weeks)

Total cholesterol

Ch

an

ge

fro

m b

ase

line

(m

g/d

l)

0

-4

-8

-12

4 8

Duration of treatment (weeks)

Triglycerides

Benolea®

Captopril

20


Clinical Study 2 Efficacy of Benolea® to improve blood lipids



Multicomponent system, develops its activity profile by

synergic effect of its components

Patented blend citrus and olive leaf extract

Efficacy and safety confirmed by

proprietary studies

Characteristics

22

Extract form

Powder

Recommended dose

400 mg/day

Standardization

Oleuropeosides ≥18% Flavonoids ≥12%


Mode of action

Antioxidant

activity

Antioxidant

activity

↑ Prostacyclin

↑ NO

“Anti-atherosclerotic action” “Vasoprotective action”

↓ Ox-LDL

↑ Vessel wall

integrity ↓ Triglycerides ↑Vascular elasticity

Digestive enzyme inhibition

+ blocking of the

association of fatty acids

with bile salt micelles


• Most cardiovascular diseases

results from complications of

atherosclerosis

• Major initiating event is the

oxidation of LDL

Lumen

Atherosclerosis


Clinical Study Efficacy of CitroliveTM to reduce triglyceride levels and ox-LDL

Participants: 23 volunteers

18-65 years-old

Inclusion criteria:

total cholesterol > 200 mg/dl and/or LDL-C > 130 mg/dl

Treatment : CitroliveTM 500 mg/day double blind trial, 3 month study

Triglyceride levels

72 70 69

43

0

10

20

30

40

50

60

70

80

90

100

Placebo Citrolive

U/L

117

124

118

106

95

100

105

110

115

120

125

130

Placebo Citrolive

mg/dL

- 15% - 38%

Ox-LDL

Baseline levels

Post-treatment levels



Characteristics

Appreciated as culinary

ingredient worldwide and long

tradition of medicinal use

Multifunctional ingredient

with triple mode of action on

blood glucose metabolism

Efficacy and safety

confirmed by

proprietary studies

Extract form

Powder

Recommended dosage

180 mg/day

27


Purslane herb: a

cosmopolitan plant

Fast growing herb, with thick,

fleshy, oval leaves

• Originating from Southern

Asia

• Growing wild or cultivated

in tropical and temperate

regions worldwide

including Mediterranean

region

Tradition

Traditional use in folk

medicine

• Used by ancient Egyptians

for a variety of conditions

including headache and

stomach pain

• Usage as antidiabetic herb

in Near East, Northern

Africa, Mexico, China

28


Activity

Increased glucose uptake from blood stream into cells

Modulation of cell sensitivity to Insulin

Reduced glucose absorption from intestine into blood stream

Triple mode of

action of

Portusana®

confirmed by

in-vitro studies

29


Clinical Study Efficacy of Portusana® to keep glucose on track

Participants: 63 subjects

31 with portusana extract

32 with placebo

Responders‘ subgroup

(participants whose HbA1c was less than baseline)

41 subjects

16 with portusana extract 25 with placebo

Effect of Purslane extract on HbA1c

-1.4

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0

6 weeks 12 weeks

Hb

A1

mea

n c

han

gen

(%

)

Placebo

Purslaneextract

* p < 0.05

Significant reduction of HbA1c by 0.85,

outperforming placebo by 44 %

12 Weeks

Randomized, double-blind placebo-controlled trial

3 CAPSULES.

OF 60MG/DAY

- Systolic blood pressure↓

- serum cholesterol group↓

30

Wainstein, J., et al.. Journal of Medicinal Food, 2016, 19(2): 133-140


In vitro Study Portusana® induces the translocation of glucose transporter 4

(GLUT4) from intracellular storage to the plasma membrane in an

insulin-like manner

31


Thanks for your attention


BELGIUM

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+32 52 319 534

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Blyinghausen 8

31655 Stadthagen

+49 (0) 5721 97500

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Km. 2, 30820 Alcantarilla, Murcia

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+1 201 941 8777

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Presentación de PowerPoint · Dyslipidemia : 50% in adult population have raised cholesterol Prediabetes : 35% in adult population ®Frutarom – Nov 17 Cardiovascular Health Phytochemicals