Actively Recruiting

Early Phase 1
Age: 18Years - 69Years
All Genders
NCT06494488

Differential Thrombogenesis by EPA and DHA Mediated by HDL

Led by The Miriam Hospital · Updated on 2025-10-01

80

Participants Needed

1

Research Sites

142 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

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.

CONDITIONS

Official Title

Differential Thrombogenesis by EPA and DHA Mediated by HDL

Who Can Participate

Age: 18Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fasting triglyceride levels between 150 and 500 mg/dL and HDL cholesterol 40 or less for men or 50 or less for women
  • LDL cholesterol greater than 40 mg/dL and up to 130 mg/dL
  • Able to provide informed consent and follow study schedules
  • Agree to maintain a low fatty fish intake diet of less than 3 servings per week
Not Eligible

You will not qualify if you...

  • Female who is pregnant, planning pregnancy during the study, or currently breastfeeding
  • Weight changes greater than 20% in the past 3 months
  • Planning significant changes in diet or exercise
  • Malabsorption syndrome or chronic diarrhea
  • Use of dietary supplements containing omega-3 fatty acids
  • Frequent consumption of 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 or psychological 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
  • Requires regular blood transfusions
  • No ethnic or racial exclusions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brown University Health - Lipid Clinic

Providence, Rhode Island, United States, 02914

Actively Recruiting

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Research Team

W

Wenliang Song, MD

CONTACT

D

Daria Salamevich

CONTACT

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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