The New Breakthrough Appetite Suppressant

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• The New Breakthrough Appetite Suppressant

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Presentation

• Obesity
• Mechanism - Appetite Suppression
• Trial PinnoThin - Results
• Recommendations
• Claims

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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

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Weight Management Market
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European National Obesity Rates
WHO-International Obesity Task Force, 2005
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Prevalence of Obesity across the World
WHO-International Obesity Task Force, 2005
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Obesity Health Risks
Cancer
Hyper- tension
Gallbladder disease
Obesity
Type 2 diabetes
Kidney Failure
Athero- sclerosis
Stroke
Heart Failure

• Estimates of obesity related costs up to 8 of
  overall health budget

WHO-International Obesity Task Force 2004
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Weight Management
Appetite Suppression
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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 C183 - 5,9,12
  (all cis)

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12
CH3
COOH
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Importance of Pine Nut Oil Origin
Korean Pine
Italian Stone Pine
Pine Nuts Korean Pine Italian Stone Pine Unit
Pinolenic acid 15 0.35
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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
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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
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Appetite controllers
CCK cholecystokinin GLP1 glucagon-like
peptide 1
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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

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Cholecystokinin (CCK)

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

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Gut responds to Fatty Acids by producing CCK
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In Vitro Activity of PinnoThin
Low dose 100 uM
High dose 300 uM
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Lipid Nutrition Human Trial at TNO, 2005

• Randomized, double blinded, placebo-controlled,
  cross-over trial
• Women n18 (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)

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CCK is increased by PinnoThin
Cholecystokinin (CCK)

PinnoThin Placebo



significant difference
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Total CCK in 4 hours after Supplementation
CCK level after PinnoThin 60 gt placebo (P lt
0.0001)
Area Under the Curve
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GLP1 is increased by PinnoThin
Glucagon like peptide 1 (GLP1)
PinnoThin Placebo


significant difference
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Total GLP1 in 4 hours after Supplementation
GLP1 level after PinnoThin 25 gt placebo
(Plt0.05)
AUC Area Under the Curve
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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

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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
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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)

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Applications

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

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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)

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LNs 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

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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

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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

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