Supplementation With Omega-3: Mechanism of Action

Study Overview
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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.

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.

Official Title
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Supplementation With Omega-3: Mechanism of Action

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: DHA-enriched
* Dietary Supplement: EPA-enriched


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA-enriched<br>DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day) | Dietary Supplement: DHA-enriched<br>* DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks<br>* Other names: Carlson Labs - Super DHA Gems;|
| Experimental: EPA-enriched<br>EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day) | Dietary Supplement: EPA-enriched<br>* EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks<br>* Other names: Carlson Labs EPA gems;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seated blood pressure | Seated blood pressure | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fish oils, Triglycerides, Blood pressure