Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

Not Applicable

• Conditions: Heart Disease
• Interventions: Dietary Supplement: EPA-DHA Study

• Registration Number: NCT01400490
• Lead Sponsor: Cardiovascular Research Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olive Oil 6 grams/day	EPA-DHA Study	-
DHA 1800 mg/day	EPA-DHA Study	-
EPA 1800 mg/day	EPA-DHA Study	-
Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day	EPA-DHA Study	-

Primary Outcome Measures

Name	Time	Method
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio	Six weeks	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.

Secondary Outcome Measures

Name	Time	Method
LpPLA2	6 weeks	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.

Trial Locations

Locations (1)

Cardiovascular Research Associates; 🇺🇸 Boston, Massachusetts, United States