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New treatment option for Lipid Metabolism Disorders
Official title Differential Thrombogenesis by EPA and DHA Mediated by HDL
ClinicalTrials.gov ID: NCT06494488
What this study is testing
What is EPA?
EPA is an investigational medicine, being studied as a potential treatment for lipid metabolism disorders.
Also referred to as eicosapentaenoic acid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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)
You likely can't join if
- Female with pregnancy, planned pregnancy (within the study period), or currently breastfeeding.
- people with weight changes greater than 20% over the past 3 months
- people 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)
See the full eligibility 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)
- Female with pregnancy, planned pregnancy (within the study period), or currently breastfeeding.
- people with weight changes greater than 20% over the past 3 months
- people 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
- people taking daily aspirin, NSAIDs, anticoagulant, or corticosteroids
- people with known bleeding disorders (for example, hemophilia)
- Known sensitivity or allergy to fish, shellfish, or omega-3 fatty acid supplements
- people requiring regular transfusions for any reason
- No ethnic/racial groups will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.