Fish Oil Study for Lipid Metabolism Disorders

This study is looking into how two types of fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), affect blood fats and platelets (tiny blood cells that help form clots) in people with high cholesterol. We want to see if these fish oils have different effects on your body. You might be able to join if you are 18 to 69 years old and have specific levels of triglycerides (a type of fat in your blood) between 150 and 500 mg/dL, and certain HDL-C (good cholesterol) and LDL-C (bad cholesterol) levels. The main goal is to measure how much your platelets clump together after 8 weeks of taking either EPA or DHA. The study is currently unclear on its status and plans to enroll 80 participants.

Study design
This is an interventional study planning to enroll 80 participants. You will be randomly assigned to receive either EPA or DHA fish oil.
What's involved
You will visit the clinic 3 times for checkups, tests, and blood collection. You will also keep a 28-day food and activity log.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome will be measured at 8 weeks.

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NCT06494488

Differential Thrombogenesis by EPA and DHA Mediated by HDL

Recruiting
EARLY_PHASE1Ages 18–69InterventionalScreening
The Miriam Hospital
~80 participants
Updated 2025-10-01 on ClinicalTrials.gov
What's tested:EPADHA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time
Measured over 8 weeks
Lipid Metabolism Disorders
Hypertriglyceridemia
1 sites across 1 states
Rhode Island1
  • Wenliang Song, MD · PRINCIPAL_INVESTIGATOR · LIFESPAN CARDIOVASCULAR INSTITUTE

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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
  • Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time8 weeks

    Platelet aggregation will be assessed as the primary endpoint. The percentage of platelet aggregation will be measured at multiple time points, and the area under the curve (AUC) will be calculated to serve as a comprehensive marker of platelet aggregation response. Data will be presented as mean ± standard deviation or other appropriate statistical summaries.