Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

NCT ID: NCT01400490

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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, 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.

Conditions

Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Olive Oil 6 grams/day

Group Type: PLACEBO_COMPARATOR

EPA-DHA Study

Intervention Type: DIETARY_SUPPLEMENT

6 weeks of dietary supplementation

DHA 1800 mg/day

Group Type: ACTIVE_COMPARATOR

EPA-DHA Study

Intervention Type: DIETARY_SUPPLEMENT

6 weeks of dietary supplementation

EPA 1800 mg/day

Group Type: ACTIVE_COMPARATOR

EPA-DHA Study

Intervention Type: DIETARY_SUPPLEMENT

6 weeks of dietary supplementation

Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day

Group Type: ACTIVE_COMPARATOR

EPA-DHA Study

Intervention Type: DIETARY_SUPPLEMENT

6 weeks of dietary supplementation

Interventions

EPA-DHA Study

6 weeks of dietary supplementation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dupont Applied Biosciences

INDUSTRY

Sponsor Role: collaborator

Cardiovascular Research Associates

NETWORK

Sponsor Role: lead

Responsible Party

Cardiovascular Research Associates

Locations

Cardiovascular Research Associates

Boston, Massachusetts, United States

Countries

United States

References

Tsunoda F, Lamon-Fava S, Asztalos BF, Iyer LK, Richardson K, Schaefer EJ. Effects of oral eicosapentaenoic acid versus docosahexaenoic acid on human peripheral blood mononuclear cell gene expression. Atherosclerosis. 2015 Aug;241(2):400-8. doi: 10.1016/j.atherosclerosis.2015.05.015. Epub 2015 May 19.

Reference Type: DERIVED

PMID: 26074314 (View on PubMed)

Other Identifiers

CVRA 2010-01

Identifier Type: -

Identifier Source: org_study_id