RECRUITINGEarly Phase 1INTERVENTIONAL
Differential Thrombogenesis by EPA and DHA Mediated by HDL
Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form and adhere to study schedules
- Agree to follow and maintain a relatively stable and low fatty fish intake diet (\<3 servings per week)
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
EPA
Fish oil
DRUG
DHA
Fish oil
Locations (1)
Brown University Health - Lipid Clinic
Providence, Rhode Island, United States