NCT06494488 · The Miriam Hospital
Differential Thrombogenesis by EPA and DHA Mediated by HDL
What this study 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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Providence, Rhode Island
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations