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The New Breakthrough Appetite Suppressant

The New Breakthrough Appetite Suppressant. Presentation. Obesity Mechanism - Appetite Suppression Trial PinnoThin™ - Results Recommendations Claims . Weight Management Market.

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The New Breakthrough Appetite Suppressant

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  1. The New Breakthrough Appetite Suppressant

  2. Presentation • Obesity • Mechanism - Appetite Suppression • Trial PinnoThin™ - Results • Recommendations • Claims

  3. 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

  4. Weight Management Market

  5. European National Obesity Rates WHO-International Obesity Task Force, 2005

  6. Prevalence of Obesity across the World WHO-International Obesity Task Force, 2005

  7. Obesity Health Risks Cancer Estimates of obesity related costs up to 8% of overall health budget* Hyper- tension Gallbladder disease Obesity Type 2 diabetes Kidney Failure Athero- sclerosis Stroke Heart Failure * WHO-International Obesity Task Force 2004

  8. Weight Management AppetiteSuppression

  9. 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) 12 9 CH3 COOH 5

  10. Importance of Pine Nut Oil Origin Korean Pine Italian Stone Pine

  11. 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

  12. 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

  13. Appetite controllers CCK: cholecystokinin GLP1: glucagon-like peptide 1

  14. 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

  15. 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., 2004 Burton-Freeman et al., Degen et al., 2001 Gutzwiller et al., 2004 McLaughlin et al., 1999 Matzinger et al., 2000 Lawton et al., 2000

  16. 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

  17. Gut responds to Fatty Acids by producing CCK

  18. In Vitro Activity of PinnoThin™ Low dose: 100 uM High dose: 300 uM

  19. 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)

  20. CCK is increased by PinnoThin™ Cholecystokinin (CCK) * PinnoThin™ Placebo * * * * = significant difference

  21. Total CCK in 4 hours after Supplementation CCK level after PinnoThin™ 60% > placebo (P < 0.0001) =Area Under the Curve

  22. GLP1 is increased by PinnoThin™ Glucagon like peptide 1 (GLP1) * PinnoThin™ Placebo * * = significant difference

  23. Total GLP1 in 4 hours after Supplementation GLP1 level after PinnoThin™ 25% > placebo (P<0.05) AUC= Area Under the Curve

  24. 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

  25. 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

  26. 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)

  27. Applications PinnoThin™ is available in • Triglyceride (TG) form Applications • As supplement in TG form • In food as TG form • Beverages, bars, dressings etc

  28. 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)

  29. 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

  30. 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

  31. 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

  32. The New Breakthrough Appetite Suppressant www.lipidnutrition.com

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