Supplementation With Omega-3: Mechanism of Action (SOMA)

Johns Hopkins University

Status and phase: Terminated; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Dietary Supplement: EPA-enriched; Dietary Supplement: DHA-enriched

Study type: Interventional

Funder types: Other

Identifiers

NCT02036307

NA_00076636

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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"

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

DHA-enriched

Experimental group

Description:

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

Treatment:

Dietary Supplement: DHA-enriched

EPA-enriched

Experimental group

Description:

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

Treatment:

Dietary Supplement: EPA-enriched