Skip to content

Supplementation With Omega-3: Mechanism of Action

Supplementation With Omega-3: Mechanism of Action

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02036307
Acronym
SOMA
Enrollment
13
Registered
2014-01-15
Start date
2013-04-30
Completion date
2015-01-31
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

Fish oils, Triglycerides, Blood pressure

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTDHA-enriched

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

DIETARY_SUPPLEMENTEPA-enriched

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

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fasting triglyceride level4 weeksFasting serum triglyceride levels

Secondary

MeasureTime frameDescription
Seated blood pressure4 weeksSeated blood pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026