Lipid Metabolism DisordersEarly Phase 1NCT06494488
Differential Thrombogenesis by EPA and DHA Mediated by HDL
A Early Phase 1 study testing EPA and DHA in people with Lipid Metabolism Disorders and Hypertriglyceridemia, run by The Miriam Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lipid Metabolism Disorders, Hypertriglyceridemia
- What is being tested?
- EPA and DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2025to 31 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brown University Health - Lipid Clinic
Providence, Rhode Island, 02914
Wenliang Song, MD, 267 951 77 59, wsong@brownhealth.org
About this study
Official title: Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)
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.
Read the 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.
- Conditions
- Lipid Metabolism Disorders, Hypertriglyceridemia
- Being tested
- EPA, DHA
- Keywords
- Fish oil, Atherogenic lipidemia, Lipoproteins
- Medical subject headings
- Lipid Metabolism Disorders, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPADrug
Also called eicosapentaenoic acid
Fish oil
DHADrug
Also called docosahexaenoic Acid
Fish oil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: EPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (8)
Percentage of Activated Platelets as Assessed by Flow Cytometry
Platelet activation will be assessed as a secondary endpoint. The percentage of activated platelets will be measured using flow cytometry, focusing on markers such as P-selectin expression and fibrinogen binding to the GPIIb/IIIa receptor. Measurements will be taken at multiple time points, and data will be summarized using statistical measures such as mean ± standard deviation.
Measured: 8 weeks
Urinary Thromboxane Metabolite Levels normalized to urinary creatinine levels in ng/mmol
Urinary thromboxane metabolite levels will be measured as a secondary endpoint to evaluate thromboxane production. Quantification will be conducted using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Results will be normalized to urinary creatinine levels (nanograms per millimole of creatinine) to account for variations in urine concentration. Data will be summarized using statistical measures such as mean ± standard deviation or other appropriate metrics.
Measured: 8 weeks
Plasma levels of CRP in mg/L
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of C-reactive protein (CRP) will be reported in milligrams per liter (mg/L) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Plasma levels of resolvins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of resolvins will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Plasma Levels of IL-6 in pg/mL
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of interleukin-6 (IL-6) will be quantified in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Plasma Levels of TNF-α in pg/mL
Inflammatory markers will be measured as secondary endpoints to evaluate systemic inflammation. Plasma levels of tumor necrosis factor-alpha (TNF-α) will be quantified in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or similar validated methods. Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Plasma levels of protectins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of protectins will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Plasma levels of maresins in pg/mL
Specialized pro-resolving mediators (SPMs) will be measured as secondary endpoints to assess their role in inflammation resolution. Plasma levels of maresins, will be quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and reported in picograms per milliliter (pg/mL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start10 Jul 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Wenliang Song, MD, Principal investigator, LIFESPAN CARDIOVASCULAR INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494488
- Sponsor's protocol ID
- 2133207
- Other IDs
- 7R01HL159204-02
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)
- ClinicalTrials.gov ID
- NCT06494488
- Acronym / sponsor ID
- 2133207
- Conditions
- Lipid Metabolism Disorders, Hypertriglyceridemia
- Keywords
- Fish oil, Atherogenic lipidemia, Lipoproteins
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA group | Experimental | Drug: DHAParticipants 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 | Drug: EPAParticipants 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPAAlso: eicosapentaenoic acidFish oil | Drug | EPA group |
| DHAAlso: docosahexaenoic AcidFish oil | Drug | DHA group |
Primary outcome
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.
8 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenliang Song, MD principal investigator
LIFESPAN CARDIOVASCULAR INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EPA and DHA in people with Lipid Metabolism Disorders and Hypertriglyceridemia, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenliang Song, MD (4014449851, WSong@Lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Platelet Aggregation Area Under the Curve (AUC) Over Time (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.