NCT01400490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

10 months

First QC Date

July 21, 2011

Last Update Submit

July 21, 2011

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • LpPLA2

    6 weeks

Study Arms (4)

Olive Oil 6 grams/day

PLACEBO COMPARATOR
Dietary Supplement: EPA-DHA Study

DHA 1800 mg/day

ACTIVE COMPARATOR
Dietary Supplement: EPA-DHA Study

EPA 1800 mg/day

ACTIVE COMPARATOR
Dietary Supplement: EPA-DHA Study

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

ACTIVE COMPARATOR
Dietary Supplement: EPA-DHA Study

Interventions

EPA-DHA StudyDIETARY_SUPPLEMENT

6 weeks of dietary supplementation

DHA 1800 mg/dayEPA 1800 mg/dayFish Oil with EPA 1800 mg/day and DHA 1200 mg/dayOlive Oil 6 grams/day

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Research Associates

Boston, Massachusetts, 02112, United States

Location

Related Publications (1)

  • 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.

    PMID: 26074314DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 22, 2011

Study Start

September 1, 2010

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

US(1)