Overview

This trial is active, not recruiting.

Condition heart disease
Treatment epa-dha study
Sponsor Cardiovascular Research Associates
Collaborator Dupont Applied Biosciences
Start date September 2010
End date July 2011
Trial size 120 participants
Trial identifier NCT01400490, CVRA 2010-01

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, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab 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,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
epa-dha study
6 weeks of dietary supplementation
(Active Comparator)
epa-dha study
6 weeks of dietary supplementation
(Active Comparator)
epa-dha study
6 weeks of dietary supplementation
(Active Comparator)
epa-dha study
6 weeks of dietary supplementation

Primary Outcomes

Measure
plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
time frame: Six weeks

Secondary Outcomes

Measure
LpPLA2
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Cardiovascular Research Associates.