NCT00988585

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cardiovascular Research Associates · Network
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPA 600	EPA 600 mg/day for 6 weeks
DIETARY_SUPPLEMENT	EPA 1800	1800 mg/day for 6 weeks
DIETARY_SUPPLEMENT	Olive Oil	600 mg/day for 6 weeks
DIETARY_SUPPLEMENT	DHA	600 mg/day for 6 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-10-02
• Last updated: 2011-06-23

Locations

1 site across 1 country: United States