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This study was suspended because there is no more funds to complete the study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA-enriched | Experimental | DHA-enriched supplement (DHA 3g + 600 mg EPA in 6 g of fish oil/day) |
|
| EPA-enriched | Experimental | EPA-enriched supplement (EPA 2.4 g + DHA 600mg in 6 g of fish oil/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA-enriched | Dietary Supplement | DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting triglyceride level | Fasting serum triglyceride levels | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seated blood pressure | Seated blood pressure | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhananjay Vaidya | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
We do not plan to share the individual patient data.
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| EPA-enriched | Dietary Supplement | EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |