Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

Heart Disease Clinical Trial

Official title:

Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01400490
• Other study ID #: CVRA 2010-01
• Status: Active, not recruiting
• Phase: N/A
• First received: July 21, 2011
• Last updated: July 21, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2011
• Source: Cardiovascular Research Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Disease

Intervention

Dietary Supplement:
• EPA-DHA Study
6 weeks of dietary supplementation

Locations

Country	Name	City	State
United States	Cardiovascular Research Associates	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Research Associates	Dupont Applied Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio	Subjects receiving EPA at 1800 mg/day will have significantly greater plasma EPA levels as well as the EPA/DHA ratio than the placebo group or the group receiving DHA, while the group receiving DHA will have significantly greater increases in plasma DHA levels as well as the DHA/EPA ratio than the placebo group or the group receiving EPA.	Six weeks	No
Secondary	LpPLA2	Subjects receiving the active supplement, especially at the 1800 mg daily dose of EPA will have significant reductions in LpPLA2 as compared to both baseline values and to the placebo group.	6 weeks	No