Actively Recruiting
Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)
Led by The Miriam Hospital · Updated on 2025-10-01
80
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
T
The Miriam Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how omega-3 fatty acid supplements, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), affect blood lipid profiles and platelet function in people with high cholesterol and related lipid disorders. The study addresses inconsistent results from previous trials and seeks to clarify whether EPA and DHA have different impacts on cardiovascular risk factors. It focuses on adults with atherogenic dyslipidemia who have specific cholesterol and triglyceride levels. Participants will be randomly assigned to take either EPA or DHA supplements for eight weeks. Those in the DHA group will take three gelcaps three times daily with meals, each containing 450 mg DHA and minimal EPA, while participants in the EPA group will take two gelcaps twice daily, each providing 1 gram of EPA. Both groups will also complete a 28-day food and activity log and maintain a low fatty fish intake diet. During the study, participants will visit the clinic three times for checkups, blood collection, and tests measuring various markers of thrombogenesis, including platelet aggregation, clotting factors, and inflammatory markers. The main outcome is the percentage of platelet aggregation over time. Secondary outcomes include levels of activated platelets, urinary thromboxane metabolites, and plasma inflammatory markers. The total participation duration is eight weeks, with ongoing monitoring of safety and adherence.
CONDITIONS
Brief Title
Differential Thrombogenesis by EPA and DHA Mediated by HDL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fasting triglyceride levels between 150 and 500 mg/dL
- HDL cholesterol 40 mg/dL or less for men, 50 mg/dL or less for women
- LDL cholesterol between 40 and 130 mg/dL
- Able to provide informed consent and follow study schedules
- Agree to maintain a relatively stable, low fatty fish diet with fewer than 3 servings per week
You will not qualify if you...
- Female who is pregnant, planning pregnancy during the study, or breastfeeding
- Weight changes greater than 20% in the past 3 months
- Planning significant changes in diet or exercise during the study
- Have malabsorption syndrome or chronic diarrhea
- Use dietary supplements containing omega-3 fatty acids
- Frequently consume omega-3 enriched fish more than 3 times per week
- Abnormal liver, kidney, or thyroid function
- Drug or alcohol abuse within 6 months or significant mental impairment
- Current smoker
- Taking daily aspirin, NSAIDs, anticoagulants, or corticosteroids
- Known bleeding disorders such as hemophilia
- Allergy or sensitivity to fish, shellfish, or omega-3 supplements
- Require regular blood transfusions
- No exclusion based on race or ethnicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive dietary supplementation with either EPA or DHA fish oil supplements for eight weeks. Various markers of thrombogenesis are assessed at baseline and after supplementation.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Brown University Health - Lipid Clinic
Providence, Rhode Island, United States, 02914
Actively Recruiting
Research Team
W
Wenliang Song, MD
D
Daria Salamevich
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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