Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil

Study Overview
=================
Brief Summary
-----------------
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Detailed Description
-----------------
The safety profile of omega-3 fatty acids is considered to be excellent, and has been recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of laboratory 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. The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.

Official Title
-----------------
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Dietary Supplement: EPA 600
* Dietary Supplement: EPA 1800
* Dietary Supplement: Olive Oil
* Dietary Supplement: DHA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male or surgically sterile females between ages 21-70. BMI of 20-35. Exclusion Criteria: competitive exerciser. current smokers. 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 units/day). those consuming more than 3 oily fish species/week. those consuming > 2 drinks/day. those with a history of a bleeding disorder, or history of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders such as uncontrolled thyroid disease, or uncontrolled hypertension or diabetes. those taking medications affecting serum lipids, body weight, or blood clotting.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Olive Oil<br>Olive Oil 600 mg/day | Dietary Supplement: Olive Oil<br>* 600 mg/day for 6 weeks<br>* Other names: Oleic acid;|
| Active Comparator: EPA 1800<br>1800 mg/day | Dietary Supplement: EPA 1800<br>* 1800 mg/day for 6 weeks<br>* Other names: fish oil;|
| Active Comparator: DHA<br>DHA 600 mg/day | Dietary Supplement: DHA<br>* 600 mg/day for 6 weeks<br>* Other names: fish oil;|
| Active Comparator: EPA 600<br>EPA 600 mg/day | Dietary Supplement: EPA 600<br>* EPA 600 mg/day for 6 weeks<br>* Other names: fish oil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No change in safety laboratory tests including comprehensive metabolic profile and complete blood count. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios. |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Disease Risk Reduction