- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400490
Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study
July 21, 2011 updated by: Cardiovascular Research Associates
Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02112
- Cardiovascular Research Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Olive Oil 6 grams/day
|
6 weeks of dietary supplementation
|
Active Comparator: DHA 1800 mg/day
|
6 weeks of dietary supplementation
|
Active Comparator: EPA 1800 mg/day
|
6 weeks of dietary supplementation
|
Active Comparator: Fish Oil with EPA 1800 mg/day and DHA 1200 mg/day
|
6 weeks of dietary supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LpPLA2
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
July 22, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVRA 2010-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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