Status:
UNKNOWN
Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study
Lead Sponsor:
Cardiovascular Research Associates
Collaborating Sponsors:
Dupont Applied Biosciences
Conditions:
Heart Disease
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, pla...
Eligibility Criteria
Inclusion
- Healthy male or surgically sterile females between ages 21-70.
- Body Mass Index of 20-35.
- Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values \> 200 ng/ml.
Exclusion
- Competitive exerciser.
- Current smoker.
- 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 mg/day).
- Those consuming more than 3 oily fish species/week.
- Those consuming \>2 drinks containing alcohol/day.
- Those taking medications which could affect serum lipids or body weight, or taking coumadin or more than 325 mg/day of aspirin which could effect bleeding time or the coagulation profile.
- History of a bleeding disorder.
- History of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders including uncontrolled diabetes, thyroid disease, or hypertension.
- Plasma LpPLA2 values \< 200 ng/ml.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01400490
Start Date
September 1 2010
End Date
September 1 2011
Last Update
July 22 2011
Active Locations (1)
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1
Cardiovascular Research Associates
Boston, Massachusetts, United States, 02112