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

Phase 1

Completed

• Conditions: Heart Disease
• Interventions: Dietary Supplement: Olive Oil; Dietary Supplement: EPA 1800; Dietary Supplement: DHA; Dietary Supplement: EPA 600

• Registration Number: NCT00988585
• Lead Sponsor: Cardiovascular Research Associates

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olive Oil	Olive Oil	Olive Oil 600 mg/day
EPA 1800	EPA 1800	1800 mg/day
DHA	DHA	DHA 600 mg/day
EPA 600	EPA 600	EPA 600 mg/day

Primary Outcome Measures

Name	Time	Method
No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.	6 weeks

Trial Locations

Locations (1)

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