Supplementation With Omega-3: Mechanism of Action

Phase 2

Terminated

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: EPA-enriched; Dietary Supplement: DHA-enriched

• Registration Number: NCT02036307
• Lead Sponsor: Johns Hopkins University

Brief Summary

This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.

Detailed Description

Observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. However, the mechanisms of action of fish oils are not well understood. Specifically, the effects of different compositions in terms of the ratio of the fatty acids EPA and DHA are not known. We are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high EPA/DHA ratio, high DHA/EPA ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . We will also bank blood and urine for future mechanistic studies. This pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-05
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Study Completion: 2015-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Healthy adults 20-75 years of age.
• Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.

Exclusion Criteria

• Current user of fish oil supplements
• Current user of statins
• Allergy to fish or seafood products
• Diagnosed/treated diabetes mellitus
• Using aspirin or NSAIDS or other "blood-thinning medication"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPA-enriched	EPA-enriched	EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day)
DHA-enriched	DHA-enriched	DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day)

Primary Outcome Measures

Name	Time	Method
Fasting triglyceride level	4 weeks	Fasting serum triglyceride levels

Secondary Outcome Measures

Name	Time	Method
Seated blood pressure	4 weeks	Seated blood pressure

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States