EPA versus DHA fish oil: effects on blood clotting and cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will randomize adults with atherogenic dyslipidemia to receive 4 grams per day of either EPA or DHA for eight weeks and collect blood and urine samples at baseline and after supplementation. The study includes three clinic visits, laboratory tests of lipids, thromboelastography, urinary thromboxane metabolites, platelet aggregation studies, and flow cytometry of platelets and platelet-leukocyte aggregates. Participants will keep a 28-day food and activity log and must limit high-fish intake during the study. The goal is a controlled, head-to-head comparison of the biological and safety effects of EPA versus DHA in a hyperlipidemic population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Brown University Health - Lipid Clinic
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Wenliang Song, MD — Lifespan Cardiovascular Institute
• Study coordinator: Wenliang Song, MD
• Email: WSong@Lifespan.org
• Phone: 4014449851

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.