Trial | NCT00988585  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    120
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.
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 Started
Apr 30
2009
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Jun 23
2011
Estimate

Dietary Supplement EPA 600

EPA 600 mg/day for 6 weeks

  • Other names: omega 3 fat, fish oil

Dietary Supplement EPA 1800

1800 mg/day for 6 weeks

  • Other names: omega 3 fat, fish oil

Dietary Supplement Olive Oil

600 mg/day for 6 weeks

  • Other names: Oleic acid

Dietary Supplement DHA

600 mg/day for 6 weeks

  • Other names: omega 3 fat, fish oil

Olive Oil Placebo Comparator

Olive Oil 600 mg/day

EPA 1800 Active Comparator

1800 mg/day

DHA Active Comparator

DHA 600 mg/day

  • Dietary Supplement DHA

EPA 600 Active Comparator

EPA 600 mg/day

Criteria 

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.
No Results Posted