Differential Thrombogenesis by EPA and DHA Mediated by HDL
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-69
SponsorThe Miriam Hospital
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- EPA
- DHA
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Miriam Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov