RecruitingEarly Phase 1NCT06494488

Differential Thrombogenesis by EPA and DHA Mediated by HDL

Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)


Sponsor

The Miriam Hospital

Enrollment

80 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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 research is to gather information on the safety and effect of two different fish oils, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants will: Visit the clinic 3 times during study checkups, tests and blood collection. Randomized to either the EPA or the DHA supplementation group. Be given a 28-day food and activity log.


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Inclusion Criteria4

  • 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 Criteria14

  • 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

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Interventions

DRUGEPA

Fish oil

DRUGDHA

Fish oil


Locations(1)

Brown University Health - Lipid Clinic

Providence, Rhode Island, United States

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NCT06494488


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