Supplementation With Omega-3: Mechanism of Action

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DHA-enriched

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

Group Type EXPERIMENTAL

DHA-enriched

Intervention Type DIETARY_SUPPLEMENT

DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks

EPA-enriched

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

Group Type EXPERIMENTAL

EPA-enriched

Intervention Type DIETARY_SUPPLEMENT

EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks

Interventions

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DHA-enriched

DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

EPA-enriched

EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Carlson Labs - Super DHA Gems Carlson Labs EPA gems

Eligibility Criteria

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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"

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes