The New Breakthrough Appetite Suppressant

Presentation

• Obesity

• Mechanism - Appetite Suppression

• Trial PinnoThin™ - Results

• Recommendations

• Claims

Weight Management Market

• In July 2003, NBJ cited the Weight Loss segment as one of the largest condition markets in the U.S. with expected market growth at 4.7%

• Appetite suppressants account for 13% of the US slimming aids market

Weight Management Market

WHO-International Obesity Task Force, 2005

European National Obesity Rates

WHO-International Obesity Task Force, 2005

Prevalence of Obesity across the World

Obesity Health Risks

Estimates of obesity related costs up to 8% of overall health budget*

Obesity

Athero-sclerosis

Type 2diabetes

Hyper-tension

HeartFailure

Stroke

KidneyFailure

Gallbladderdisease

Cancer

* WHO-International Obesity Task Force 2004

Weight Management

Appetite Suppression

Where does PinnoThin™ come from?

• Over 144 pine trees exist

• PinnoThin™ comes from the Korean pine tree (Pinus koraiensis)

• Pinus koraiensis grows in Korea, Japan, Siberia and Manchouria (North of China)

• PinnoThin™ contains pinolenic acid

• Pinolenic acid – LCPUFA – Omega-6: C18:3 - 5,9,12 (all cis)

CH3 COOH

5

912

Korean Pine Italian Stone Pine

Importance of Pine Nut Oil Origin

Pine Nuts Korean Pine Italian Stone Pine Unit

Pinolenic acid 15 0.35 %

Regulation of Digestion and Absorption of Food

• Regulated by

• Hormonal system

• Nervous system

• Reasons for meal termination:

• Fullness or absence of hunger

• Decline in pleasantness or reward value of the food being eaten

Graaf, de et al., 2004

Meal Termination:

Depends on:

• Short-term signals such as stomach distension and on gut hormones like cholecystokinin (CCK) and glucagon-like peptide 1 (GLP1)

• Sensitivity to these short-term signals is affected by signals that work in the long term like leptin and grhelin

Graaf, de et al., 2004

Appetite controllers

CCK: cholecystokininGLP1: glucagon-like peptide 1

Cholecystokinin (CCK)

• Small intestinal hormone (first part)

• Reduces appetite and food intake

• Determines meal size or meal termination (satiation)

• Released upon fat or protein intake

• Slows down gastric emptying

Cholecystokinin (CCK)

• CCK suppresses appetite, and higher amounts of CCK produce larger appetite-suppressing effects

• Fatty acids > C10 are effective in releasing CCK

• Long chain fatty acids are more effective than medium chain fatty acids

• Poly unsaturated fatty acids are more effective than mono-unsaturated fatty acids

Burton-Freeman et al., 2004Burton-Freeman et al., Degen et al., 2001Gutzwiller et al., 2004McLaughlin et al., 1999Matzinger et al., 2000Lawton et al., 2000

Glucagon-like peptide 1 (GLP1)

• Small intestinal hormone (last part)

• Reduces appetite and food intake

• Determines meal size or meal termination (satiation)

• Released upon fat and carbohydrates intake

• Delays gastric emptying

Gut responds to Fatty Acids by producing CCK

In Vitro Activity of PinnoThin™

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Marinol™ PinnoThin™

CC

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Low dose: 100 uM

High dose: 300 uM

Lipid Nutrition Human Trial at TNO, 2005

• Randomized, double blinded, placebo-controlled, cross-over trial

• Women n=18 (all women tested placebo and PinnoThin™) • BMI = 25 – 30 (mean BMI = 27.4 ± 1.6)

• Age = 55 ± 4

• Weight = 76.7 ± 6.7

• Overnight fasting

• Simple breakfast + 3 g of supplement in capsules:• PinnoThin™ or

• Placebo (olive oil)

• Subjects were monitored during 4 hours:• Satiety score (VAS) (subjective)

• CCK and GLP1 levels (objective)

PinnoThin™Placebo

CCK is increased by PinnoThin™

*

*

**

* = significant difference

Cholecystokinin (CCK)

0

50

100

150

200

250

Placebo PinnoThin™

AUC

CCK level after PinnoThin™ 60% > placebo (P < 0.0001)

Total CCK in 4 hours after Supplementation

=Area Under the Curve

GLP1 is increased by PinnoThin™

PinnoThin™ Placebo

*

*

* = significant difference

Glucagon like peptide 1 (GLP1)

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Placebo PinnoThin™

GLP1 level after PinnoThin™ 25% > placebo (P<0.05)

Total GLP1 in 4 hours after Supplementation

AUC = Area Under the Curve

Summary of the results

• PinnoThin™ significantly increases CCK and GLP1 in blood within 30-60 min

• Total CCK and GLP1 levels remain higher than placebo for at least 3 hours after PinnoThin™ intake

• Desire to eat and the prospective intake scores are significantly lower after 30 min

• PinnoThin™ reduces the desire to eat with 29% at 30 minutes relative to placebo

• PinnoThin™ reduces the prospective food intake with 36% at 30 minutes relative to placebo

Conclusion

• PinnoThin™ may thus affect meal size

Recommendations

• To reduce meal size

• 3 g PinnoThin™ 30 – 60 minutes before a meal

• Intake ideally before meal with highest energy content

• To reduce snacking

• 3 g PinnoThin™ in between meals

Maximal daily dose is 6 g per day

Safety of 6 g / day

• History of use in humans

• Animal studies

• Ames-test using Pine Nut Oil

• Clearance from Covance

(The Development Services Company)

PinnoThin™ is available in

• Triglyceride (TG) form

Applications

• As supplement in TG form

• In food as TG form

• Beverages, bars, dressings etc

Applications

Regulatory & Patents

Regulatory

• EU: not a Novel Ingredient because of history of use

• US: PinnoThin™ TG is GRAS

PinnoThin™ FFA - NDI submission will be filed,

expectations for allowance end 2005

Patents

• PinnoThin™ is protected for its specific uses in food, food supplements and pharmaceuticals

• Patent PinnoThin™ as health component (EP 1088552 US6479070 JP 300280/00 KR 10200057291)

• Patent on composition (EP 1088552)

LN’s Patented Claims include:

• PinnoThin™ promotes the feeling of satiety

• PinnoThin™ suppresses the desire to eat

• PinnoThin™ reduces the prospective food intake

• PinnoThin™ significantly increases the release of CCK

• PinnoThin™ significantly increases the release of GLP1

Examples Consumer Claims

• PinnoThin™ is an effective appetite suppressant *

• PinnoThin™ can help to reduce your caloric intake

• PinnoThin™ can help to reduce snacking

• PinnoThin™ supports to reduce the food intake

• PinnoThin™ can control your weight

• PinnoThin™ gives you control on your appetite

* Structure-function claim FDA

These claims are not approved by the FDA and the use of these claims depend on the regulations in

your country

Why PinnoThin™?

• PinnoThin™ is a scientifically proven appetite suppressant

• PinnoThin™ is derived from a natural (vegetable) source

• PinnoThin™ contains the effective components

• PinnoThin™ is easy to use

• PinnoThin™ can be taken every day

The New Breakthrough

Appetite Suppressant

www.lipidnutrition.com