NCT06494488 Differential Thrombogenesis by EPA and DHA Mediated by HDL
| NCT ID | NCT06494488 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The Miriam Hospital |
| Condition | Lipid Metabolism Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-07-10 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Wenliang Song, MD
PRINCIPAL INVESTIGATOR
LIFESPAN CARDIOVASCULAR INSTITUTE
Frequently Asked Questions
Who can join the NCT06494488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 69 Years, studying Lipid Metabolism Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06494488 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06494488 currently recruiting?
Yes, NCT06494488 is actively recruiting participants. Contact the research team at WSong@Lifespan.org for enrollment information.
Where is the NCT06494488 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06494488 clinical trial?
NCT06494488 is sponsored by The Miriam Hospital. The principal investigator is Wenliang Song, MD at LIFESPAN CARDIOVASCULAR INSTITUTE. The trial plans to enroll 80 participants.