Health TrialsbyHealthPanel

Differential Thrombogenesis by EPA and DHA Mediated by HDL

ConditionsLipid Metabolism DisordersHypertriglyceridemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EPA

    Drug

    Fish oil

  • DHA

    Drug

    Fish oil

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DHA groupExperimental treatment 1 intervention
Group B: EPA groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Miriam Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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