Recruiting
Early Phase 1

EPA & DHA

Sponsor:

The Miriam Hospital

Code:

NCT06494488

Conditions

Lipid Metabolism Disorders

Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

EPA

DHA

Study Details

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.

Conditions

Lipid Metabolism Disorders

Hypertriglyceridemia

Study ID

NCT06494488

Start date

Jul 10, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: DHA group

Participants will receive DHA supplement. 3 gelcaps, three times per day with meals (breakfast, lunch, and dinner). DHA supplement regimen contains 450 mg DHA and minimal EPA (60 mg) per pill.

Participants will be given 28-day food and activity log.

experimental: EPA group

Participants will receive EPA supplement. 2 gelcaps, two times per day with meals (breakfast and dinner). 1 gelcap consists of 1 gram of EPA.

Participants will be given 28-day food and activity log.

Interventions

EPA

Fish oil

DHA

Fish oil

Primary outcome measure

  • Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Wenliang Song, MD

4014449851WSong@Lifespan.org

Daria Salamevich

4014449857DSalamevich@Lifespan.org

Locations

Brown University Health - Lipid Clinic

Recruiting

Providence, Rhode Island, United States, 02914

Contacts

Wenliang Song, MD

267 951 77 59wsong@brownhealth.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • Fish oil
  • Atherogenic lipidemia
  • Lipoproteins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2025-10-01.