Dr Jeff Leighton, Chief Science Officer and Vanessa Whiting, Senior Nutritionist

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1 Dr Jeff Leighton, Chief Science Officer and Vanessa Whiting, Senior Nutritionist

2 # of Health Benefits CV..2-3 grams TGs.4 grams Inflammation..> 4 grams CNS? Women s Health.? G.I. (Leaky Gut)..? DOSE Variables: Exercise BMI Diet Chronic Disease Age Gender

3 Max # of Health Benefits? % Omega 3 Incorporation We need to correlate % omega 3 incorporation with health benefit Assuming the use of a highly potent omega 3 oil and an optimized formulation and dosing regimen, what is the practical upper limit to omega 3 oil incorporation?

4 Abstain from all Omega 3 supplements for 30 days Measure Omega 3 (baseline) Dose for 30 days Food and exercise survey filled out on a daily basis allowing verification of diet, exercise and pain Measure Omega 3 In a subset group, measured rate of loss of Omega 3 (7 day and 30 day) Study involved 136 volunteers Volunteers were recruited largely from the Northeast region

5 Omega 3 Index Assay Developed by Dr. Bill Harris CLEA Approved finger prick assay Detects % of Omega 3 fats in RBC membranes SFH Omega 3 Oil IFOS certified CRN, GOED compliant Dose strength per 5 ml (1 teaspoon) EPA 2235mg DHA 990mg Total 3225mg/ 5 ml Ratio Omega 3: Omega 6 37:1 Fatty acids are in triglyceride form

6 1. What is the best dosing paradigm to optimize Omega 3 fat incorporation? Once a day? Twice a day? With food? 1 tsp vs 2 tsp of SFH Omega 3 oil? 2. Does BMI, gender, age, exercise or chronic disease affect Omega 3 fat incorporation? 3. What is the rate of loss of Omega 3 fats following a steady state dosing period?

Dose Optimization summary 121/ 10.32 122/ 10.38 220/ 15.04 100 75 42% 20% 79/ 8.36 99/ 9.29 50 Basal 34.9/ 6.30 25 14.6/ 5.35 17.5/ 5.49 Ave 4.

7 Dose Optimization summary 121/ / / % 20% 79/ / Basal 34.9/ / / 5.49 Ave 4.67% Athletes No fish and no fish oil Fish 1x week, no omega 3 oil 1 tps fish oil, no food 2 tps fish oil, no food 2 tps fish oil with food once a day 2 tps fish oil BID No nuts, low carb, red meat 3x/ week

8 BMI Diet Number Baseline % Stimulated % Stand. American Low Carb Stand. American Low Carb >30 Stand. American Low Carb Conclusion: the combination of low carb and low BMI translates into greater basal and stimulated omega 3

9 BMI Number Inflammation? Baseline % Stimulated % Yes No Yes No >30 5 Yes No * Inflammation does not affect Omega 3 incorporation. As in other studies, individuals with BMI >25 have lower baseline and stimulated Omega 3 incorporation

10 Number Baseline % Stimulated % ALL Males Females Conclusion: Gender has no effect on omega 3 incorporation

11 BMI Number Baseline % Stimulated % >30 ALL Males Females ALL Males Females ALL Male Female Conclusion: Effects of BMI on Omega 3 incorporation are modest but a healthy BMI shows higher baseline and higher incorporation efficiency

12 BMI Number Pre Post Baseline % Stimulated % > Estrogen state has little effect on omega 3 oil incorporation (preliminary conclusion). Larger study group required.

13 100 % Change 80 from baseline 50 X 9.71% 7.36% X X 5.61% Steady State Days 30 N=10, all athletes, athlete baseline 5.41% T ½ for Omega 3 loss approximately 7 days

14 1. Individuals with a healthy BMI (18-25) have higher basal and stimulated omega 3 incorporation. 2. There is considerable dosing flexibility. A BID dose or once a day just before or with food provides optimal omega 3 incorporation. 3. It is possible to increase omega 3 incorporation to approximately 15% with a low carb/ low omega 6 diet (no nuts, with fish and red meat 3 days / week). 4. Individuals in generally good health, but not athletic have an average omega 3 basal incorporation of 4.67%. 5. Athletes have a higher basal omega 3 incorporation of 5.35% 6. Age and diagnosed inflammation have no effect on omega 3 fat incorporation. 7. Gender has no effect on omega 3 oil incorporation. 8. Surprisingly, the t ½ for omega 3 loss is short (approximately 7 days) despite being a lipid soluble fatty acid. The observation was from a group of 10 athletes where exercise induced cell metabolism would be expected to increase turnover of muscle and energy stores. 9. With modest changes in diet, it is reasonable to achieve 9-10% incorporation of omega 3 into cell membranes What are the maximum number of health benefits achieved with 10% omega 3 oil incorporation TBD!

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER 2. SYNOPSIS Title of Study: An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of and a Single Dose of Rosuvastatin (Crestor ), to Assess the Dose Proportionality of,