Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Cardiovascular Research Associates.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dupont Applied Biosciences
Information provided by:
Cardiovascular Research Associates
ClinicalTrials.gov Identifier:
NCT01400490
First received: July 21, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Disease
Dietary Supplement: EPA-DHA Study

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)

Resource links provided by NLM:


Further study details as provided by Cardiovascular Research Associates:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • LpPLA2 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Olive Oil 6 grams/day Dietary Supplement: EPA-DHA Study
6 weeks of dietary supplementation
Active Comparator: DHA 1800 mg/day Dietary Supplement: EPA-DHA Study
6 weeks of dietary supplementation
Active Comparator: EPA 1800 mg/day Dietary Supplement: EPA-DHA Study
6 weeks of dietary supplementation
Active Comparator: Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day Dietary Supplement: EPA-DHA Study
6 weeks of dietary supplementation

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400490

Locations
United States, Massachusetts
Cardiovascular Research Associates
Boston, Massachusetts, United States, 02112
Sponsors and Collaborators
Cardiovascular Research Associates
Dupont Applied Biosciences
  More Information

No publications provided

Responsible Party: Michael L. Dansinger, MD, Cardiovascular Research Associates
ClinicalTrials.gov Identifier: NCT01400490     History of Changes
Other Study ID Numbers: CVRA 2010-01
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014