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

February 28, 2017 updated by: Dhananjay Vaidya, Johns Hopkins University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DHA-enriched
DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day)
Dietary supplement: DHA-enriched
DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks
Other Names:
  • Carlson Labs - Super DHA Gems
EXPERIMENTAL: EPA-enriched
EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day)
Dietary supplement: EPA-enriched
EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks
Other Names:
  • Carlson Labs EPA gems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting triglyceride level
Time Frame: 4 weeks
Fasting serum triglyceride levels
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seated blood pressure
Time Frame: 4 weeks
Seated blood pressure
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Dhananjay Vaidya, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00076636

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share the individual patient data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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