Clinical trial NCT01400490: Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study
Official title: Evaluation of the Biologic Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)-Enriched Oils (EPA-DHA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Disease
Lead sponsor: Cardiovascular Research Associates
Sponsor class: NETWORK
Collaborators: name: Dupont Applied Biosciences
First posted: 2011-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: plasma EPA levels as well as the EPA/DHA ratio and plasma DHA levels as well as the DHA/EPA ratio
timeFrame: Six weeks
Secondary outcomes:
measure: LpPLA2
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Cardiovascular Research Associates
state: Massachusetts
Study officials:
References:
citation: 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.