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Search / Trial NCT06494488

Differential Thrombogenesis by EPA and DHA Mediated by HDL

Launched by THE MIRIAM HOSPITAL · Jul 2, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Fish Oil Atherogenic Lipidemia Lipoproteins

ClinConnect Summary

This clinical trial is studying how two types of omega-3 fatty acids, EPA and DHA, found in fish oil, affect cholesterol levels and blood platelets in people with high cholesterol. The researchers want to find out how safe these supplements are and how they might improve the way our bodies handle fats in the blood.

To participate, individuals need to be aged 25 to 74 and have specific cholesterol levels, including high triglycerides and low HDL (the "good" cholesterol). Participants will visit the clinic five times over the study and will be asked to keep a 28-day record of their food and activity. It's important for those interested to note that they should not be pregnant, breastfeeding, or planning to change their diet or exercise significantly during the study. This trial is not yet recruiting, but if you meet the criteria and are interested, more information will be available soon.

Gender

ALL

Eligibility criteria

  • 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

About The Miriam Hospital

The Miriam Hospital, a leading academic medical center affiliated with Brown University, is dedicated to advancing healthcare through innovative clinical research and patient-centered care. Renowned for its commitment to medical excellence, the hospital conducts a wide range of clinical trials aimed at improving treatment outcomes across various specialties, including cardiology, oncology, and infectious diseases. With a focus on translating research findings into practice, The Miriam Hospital fosters collaborations among multidisciplinary teams to enhance the quality of care and promote health equity within the community and beyond.

Locations

Patients applied

0 patients applied

Trial Officials

Wenliang Song, MD

Principal Investigator

LIFESPAN CARDIOVASCULAR INSTITUTE

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported