NCT01400490

Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cardiovascular Research Associates · Network
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPA-DHA Study	6 weeks of dietary supplementation

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2011-07-22
• Last updated: 2011-07-22

Locations

1 site across 1 country: United States