Differential Thrombogenesis by EPA and DHA Mediated by HDL

NCT06494488 | Recruiting Early Phase 1 DMC

• 2 other identifiers: 21332077R01HL159204-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Fish oil; Atherogenic lipidemia; Lipoproteins

Outcome Measures

Primary Outcomes (1)

• Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time

  Platelet aggregation will be assessed as the primary endpoint. The percentage of platelet aggregation will be measured at multiple time points, and the area under the curve (AUC) will be calculated to serve as a comprehensive marker of platelet aggregation response. Data will be presented as mean ± standard deviation or other appropriate statistical summaries.

  8 weeks

Secondary Outcomes (8)

• Percentage of Activated Platelets as Assessed by Flow Cytometry

  8 weeks

• Urinary Thromboxane Metabolite Levels normalized to urinary creatinine levels in ng/mmol

  8 weeks

• Plasma levels of CRP in mg/L

  8 weeks

• Plasma levels of resolvins in pg/mL

  8 weeks

• Plasma Levels of IL-6 in pg/mL

  8 weeks

Study Arms (2)

DHA group

EXPERIMENTAL

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.

Drug: DHA

EPA group

EXPERIMENTAL

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.

Drug: EPA

Interventions

EPA DRUG

Fish oil

Also known as: eicosapentaenoic acid

EPA group

DHA DRUG

Fish oil

Also known as: docosahexaenoic Acid

DHA group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brown University Health - Lipid Clinic

Providence, Rhode Island, 02914, United States

RECRUITING

MeSH Terms

Conditions

Lipid Metabolism Disorders; Hypertriglyceridemia

Interventions

Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Dyslipidemias

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Wenliang Song, MD

  LIFESPAN CARDIOVASCULAR INSTITUTE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenliang Song, MD

CONTACT

4014449851; WSong@Lifespan.org

Daria Salamevich

CONTACT

4014449857; DSalamevich@Lifespan.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: July 10, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)