Status:
COMPLETED
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
Lead Sponsor:
Cardiovascular Research Associates
Collaborating Sponsors:
Dupont Applied Biosciences
Conditions:
Heart Disease
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
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 supple...
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 ...
Eligibility Criteria
Inclusion
- healthy male or surgically sterile females between ages 21-70.
- BMI of 20-35.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00988585
Start Date
April 1 2009
End Date
December 1 2009
Last Update
June 23 2011
Active Locations (1)
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1
Cardiovascular Research Associates
Boston, Massachusetts, United States, 02111