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

Cardiovascular Research Associates

Status and phase: Completed; Phase 1

Conditions: Heart Disease

Treatments: Dietary Supplement: EPA 1800; Dietary Supplement: Olive Oil; Dietary Supplement: DHA; Dietary Supplement: EPA 600

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00988585

Dupont-0609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Olive Oil

Placebo Comparator group

Description:

Olive Oil 600 mg/day

Treatment:

Dietary Supplement: Olive Oil

EPA 1800

Active Comparator group

Description:

1800 mg/day

Treatment:

Dietary Supplement: EPA 1800

DHA

Active Comparator group

Description:

DHA 600 mg/day

Treatment:

Dietary Supplement: DHA

EPA 600

Active Comparator group

Description:

EPA 600 mg/day

Treatment:

Dietary Supplement: EPA 600