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Supplementation With Omega-3: Mechanism of Action

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertriglyceridemia

Intervention: DHA-enriched (Dietary Supplement); EPA-enriched (Dietary Supplement)

Phase: Phase 2

Status: Suspended

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Dhananjay Vaidya, Principal Investigator, Affiliation: Johns Hopkins University

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.

Clinical Details

Official title: Supplementation With Omega-3: Mechanism of Action

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Fasting triglyceride level

Secondary outcome: Seated blood pressure

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.

Eligibility

Minimum age: 20 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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"

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21287, United States
Additional Information

Starting date: April 2013
Last updated: February 13, 2014

Page last updated: August 23, 2015

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