Clinical trial NCT00988585: Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
Official title: Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Disease
Keywords: Heart Disease Risk Reduction
Lead sponsor: Cardiovascular Research Associates
Sponsor class: NETWORK
Collaborators: name: Dupont Applied Biosciences
First posted: 2009-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: No change in safety laboratory tests including comprehensive metabolic profile and complete blood count.
timeFrame: 6 weeks
Secondary outcomes:
measure: Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Cardiovascular Research Associates
state: Massachusetts
Study officials:
affiliation: Cardiovascular Research Associates
name: Michael L Dansiner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: