Status:
RECRUITING
Differential Thrombogenesis by EPA and DHA Mediated by HDL
Lead Sponsor:
The Miriam Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lipid Metabolism Disorders
Hypertriglyceridemia
Eligibility:
All Genders
18-69 years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this study is to learn more about omega-3 polyunsaturated fatty acids supplementation on blood lipid profile and platelets in patients with high cholesterol levels. The purpose of this re...
Detailed Description
Epidemiological studies suggest that consumption of omega-3 polyunsaturated fatty acids (n-3 PUFAs) derived from fish oil, mainly consisting of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DH...
Eligibility Criteria
Inclusion
- Fasting TG levels ≥ 150 mg/dL and \< 500 mg/dL and HDL-C ≤ 40 (men) or ≤ 50 (women)
- LDL-C \> 40 mg/dL and ≤ 130 mg/dL
- Able to provide informed consent and adhere to study schedules
- Agree to follow and maintain a relatively stable and low fatty fish intake diet (\<3 servings per week)
Exclusion
- Female with pregnancy, planned pregnancy (within the study period), or currently breastfeeding.
- Subjects with weight changes greater than 20% over the past 3 months
- Subjects planning a significant change in diet or exercise levels
- Malabsorption syndrome and/or chronic diarrhea
- Use of dietary supplements containing n-3 PUFA fatty acids
- Frequent consumption of n-3 PUFA-enriched fish (\>3 times a week)
- Abnormal liver, kidney, or thyroid functions
- Drug or alcohol abuse within 6 months or significant mental/psychological impairment
- Current smokers
- Subjects taking daily aspirin, NSAIDs, anticoagulant, or corticosteroids
- Subjects with known bleeding disorders (for example, hemophilia)
- Known sensitivity or allergy to fish, shellfish, or omega-3 fatty acid supplements
- Subjects requiring regular transfusions for any reason
- No ethnic/racial groups will be excluded
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06494488
Start Date
July 10 2025
End Date
March 31 2028
Last Update
October 1 2025
Active Locations (1)
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1
Brown University Health - Lipid Clinic
Providence, Rhode Island, United States, 02914