Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

Study Overview
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Brief Summary
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The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.

Official Title
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Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)

Conditions
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Heart Disease

Intervention / Treatment
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* Dietary Supplement: EPA-DHA Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or surgically sterile females between ages 21-70. Body Mass Index of 20-35. Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values > 200 ng/ml. Exclusion Criteria: Competitive exerciser. Current smoker. Those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (>500 mg/day) or vitamin E (>400 mg/day). Those consuming more than 3 oily fish species/week. Those consuming >2 drinks containing alcohol/day. Those taking medications which could affect serum lipids or body weight, or taking coumadin or more than 325 mg/day of aspirin which could effect bleeding time or the coagulation profile. History of a bleeding disorder. History of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders including uncontrolled diabetes, thyroid disease, or hypertension. Plasma LpPLA2 values < 200 ng/ml.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Olive Oil 6 grams/day<br> | Dietary Supplement: EPA-DHA Study<br>* 6 weeks of dietary supplementation<br>|
| Active Comparator: DHA 1800 mg/day<br> | Dietary Supplement: EPA-DHA Study<br>* 6 weeks of dietary supplementation<br>|
| Active Comparator: EPA 1800 mg/day<br> | Dietary Supplement: EPA-DHA Study<br>* 6 weeks of dietary supplementation<br>|
| Active Comparator: Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day<br> | Dietary Supplement: EPA-DHA Study<br>* 6 weeks of dietary supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio | Subjects receiving EPA at 1800 mg/day will have significantly greater plasma EPA levels as well as the EPA/DHA ratio than the placebo group or the group receiving DHA, while the group receiving DHA will have significantly greater increases in plasma DHA levels as well as the DHA/EPA ratio than the placebo group or the group receiving EPA. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LpPLA2 | Subjects receiving the active supplement, especially at the 1800 mg daily dose of EPA will have significant reductions in LpPLA2 as compared to both baseline values and to the placebo group. | 6 weeks |