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

Completed · Phase 1

Conditions studied: Heart Disease

In brief

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.

Key facts

Study ID

NCT00988585

Run by

Cardiovascular Research Associates

People needed

120

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2011-06-23

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy male or surgically sterile females between ages 21-70.
• BMI of 20-35.

You may not qualify if…

• 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.

Where it is running

• Cardiovascular Research Associates — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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