Supplementation With Omega-3: Mechanism of Action

Hypertriglyceridemia Clinical Trial

— SOMA  

Official title:

Supplementation With Omega-3: Mechanism of Action

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02036307
• Other study ID #: NA_00076636
• Status: Terminated
• Phase: Phase 2
• First received: January 13, 2014
• Last updated: February 28, 2017
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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"

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• DHA-enriched
DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks
• EPA-enriched
EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting triglyceride level	Fasting serum triglyceride levels	4 weeks
Secondary	Seated blood pressure	Seated blood pressure	4 weeks