---
title: Differential Thrombogenesis by EPA and DHA Mediated by HDL
nct_id: NCT06494488
overall_status: RECRUITING
phase: EARLY_PHASE1
sponsor: The Miriam Hospital
study_type: INTERVENTIONAL
primary_condition: Lipid Metabolism Disorders
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06494488.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06494488"
ct_last_update_post_date: 2025-10-01
last_seen_at: "2026-05-12T07:01:16.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Differential Thrombogenesis by EPA and DHA Mediated by HDL

**Official Title:** Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)

**NCT ID:** [NCT06494488](https://clinicaltrials.gov/study/NCT06494488)

## Key Facts

- **Status:** RECRUITING
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** The Miriam Hospital
- **Collaborators:** National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- **Conditions:** Lipid Metabolism Disorders, Hypertriglyceridemia
- **Start Date:** 2025-07-10
- **Completion Date:** 2028-03-31
- **CT.gov Last Update:** 2025-10-01

## 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.

## Detailed Description

Epidemiological studies suggest that consumption of omega-3 polyunsaturated fatty acids (n-3 PUFAs) derived from fish oil, mainly consisting of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is associated with lower cardiovascular risk. However, interventional clinical trials aimed at reducing cardiovascular incidents by n-3 PUFAs supplementations have yielded inconsistent results. An intriguing fact is that only the outcome trials using EPA, but not those testing EPA/DHA mixed regimens, showed beneficial results. This discrepancy begs the question of whether EPA and DHA have differential effects and whether DHA blunts the cardiovascular benefits of EPA. However, no head-to-head clinical trial comparison of the biological effects of EPA and DHA in the hyperlipidemia patients has been reported. Hence, a well-designed, controlled, proof-of-concept clinical study testing EPA versus DHA in a relevant population is urgently required. In this study, the human subjects with atherogenic dyslipidemia will be randomized to dietary supplementation with four grams of either EPA or DHA n-3 PUFAs for eight weeks. At baseline and after the supplementation, various markers of thrombogenesis will be assessed, including biomarkers of the clotting cascade, thromboelastography, urinary thromboxane metabolites, whole blood aggregation, platelet aggregation, and flow cytometry analysis of platelets and platelet-leukocyte aggregates will also be performed.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 69 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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.

## Interventions

- **EPA** (DRUG) — Fish oil
- **DHA** (DRUG) — Fish oil

## Primary Outcomes

- **Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time** _(time frame: 8 weeks)_ — 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.

## Secondary Outcomes

- **Percentage of Activated Platelets as Assessed by Flow Cytometry** _(time frame: 8 weeks)_
- **Urinary Thromboxane Metabolite Levels normalized to urinary creatinine levels in ng/mmol** _(time frame: 8 weeks)_
- **Plasma levels of CRP in mg/L** _(time frame: 8 weeks)_
- **Plasma levels of resolvins in pg/mL** _(time frame: 8 weeks)_
- **Plasma Levels of IL-6 in pg/mL** _(time frame: 8 weeks)_
- **Plasma Levels of TNF-α in pg/mL** _(time frame: 8 weeks)_
- **Plasma levels of protectins in pg/mL** _(time frame: 8 weeks)_
- **Plasma levels of maresins in pg/mL** _(time frame: 8 weeks)_

## Locations (1)

- Brown University Health - Lipid Clinic, Providence, Rhode Island, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.brown university health - lipid clinic|providence|rhode island|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06494488.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06494488*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*