[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06494488":3,"trial-entities:NCT06494488":135,"trial-summary:NCT06494488":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":51,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":102,"locations":105,"central_contacts":121,"overall_officials":129,"references":133,"see_also_links":134},"NCT06494488","2133207","Differential Thrombogenesis by EPA and DHA Mediated by HDL","Differential Thrombogenesis Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Mediated by High-Density Lipoprotein (HDL)","RECRUITING","2028-03-31","2025-09","2025-10-01","2025-07-10","The Miriam Hospital","OTHER",true,"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.\n\nThe 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).\n\nParticipants will:\n\nVisit 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.","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\u002FDHA 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.",[19,20],"Lipid Metabolism Disorders","Hypertriglyceridemia",[22,23,24],"Fish oil","Atherogenic lipidemia","Lipoproteins","INTERVENTIONAL","SCREENING",[28],"EARLY_PHASE1",{"count":30,"type":31},80,"ESTIMATED",[33,40],{"type":34,"name":35,"description":22,"armGroupLabels":36,"otherNames":38},"DRUG","EPA",[37],"EPA group",[39],"eicosapentaenoic acid",{"type":34,"name":41,"description":22,"armGroupLabels":42,"otherNames":44},"DHA",[43],"DHA group",[45],"docosahexaenoic Acid",[47],{"measure":48,"description":49,"timeFrame":50},"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",[52,55,58,61,64,67,70,73],{"measure":53,"description":54,"timeFrame":50},"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\u002FIIIa receptor. Measurements will be taken at multiple time points, and data will be summarized using statistical measures such as mean ± standard deviation.",{"measure":56,"description":57,"timeFrame":50},"Urinary Thromboxane Metabolite Levels normalized to urinary creatinine levels in ng\u002Fmmol","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\u002FMS). 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.",{"measure":59,"description":60,"timeFrame":50},"Plasma levels of CRP in mg\u002FL","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\u002FL) 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.",{"measure":62,"description":63,"timeFrame":50},"Plasma levels of resolvins in pg\u002FmL","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\u002FMS) and reported in picograms per milliliter (pg\u002FmL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.",{"measure":65,"description":66,"timeFrame":50},"Plasma Levels of IL-6 in pg\u002FmL","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\u002FmL) 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.",{"measure":68,"description":69,"timeFrame":50},"Plasma Levels of TNF-α in pg\u002FmL","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\u002FmL) 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.",{"measure":71,"description":72,"timeFrame":50},"Plasma levels of protectins in pg\u002FmL","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\u002FMS) and reported in picograms per milliliter (pg\u002FmL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.",{"measure":74,"description":75,"timeFrame":50},"Plasma levels of maresins in pg\u002FmL","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\u002FMS) and reported in picograms per milliliter (pg\u002FmL). Data will be summarized using statistical measures such as mean ± standard deviation, and comparisons will be made across study groups and time points.","ALL","18 Years","69 Years",false,{"inclusion":81,"exclusion":86,"raw_text":101},[82,83,84,85],"Fasting TG levels ≥ 150 mg\u002FdL and \\\u003C 500 mg\u002FdL and HDL-C ≤ 40 (men) or ≤ 50 (women)","LDL-C \\> 40 mg\u002FdL and ≤ 130 mg\u002FdL","Able to provide informed consent and adhere to study schedules","Agree to follow and maintain a relatively stable and low fatty fish intake diet (\\\u003C3 servings per week)",[87,88,89,90,91,92,93,94,95,96,97,98,99,100],"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\u002For 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\u002Fpsychological 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\u002Fracial groups will be excluded","Inclusion Criteria:\n\n* Fasting TG levels ≥ 150 mg\u002FdL and \\\u003C 500 mg\u002FdL and HDL-C ≤ 40 (men) or ≤ 50 (women)\n* LDL-C \\> 40 mg\u002FdL and ≤ 130 mg\u002FdL\n* Able to provide informed consent and adhere to study schedules\n* Agree to follow and maintain a relatively stable and low fatty fish intake diet (\\\u003C3 servings per week)\n\nExclusion Criteria:\n\n* Female with pregnancy, planned pregnancy (within the study period), or currently breastfeeding.\n* Subjects with weight changes greater than 20% over the past 3 months\n* Subjects planning a significant change in diet or exercise levels\n* Malabsorption syndrome and\u002For chronic diarrhea\n* Use of dietary supplements containing n-3 PUFA fatty acids\n* Frequent consumption of n-3 PUFA-enriched fish (\\>3 times a week)\n* Abnormal liver, kidney, or thyroid functions\n* Drug or alcohol abuse within 6 months or significant mental\u002Fpsychological impairment\n* Current smokers\n* Subjects taking daily aspirin, NSAIDs, anticoagulant, or corticosteroids\n* Subjects with known bleeding disorders (for example, hemophilia)\n* Known sensitivity or allergy to fish, shellfish, or omega-3 fatty acid supplements\n* Subjects requiring regular transfusions for any reason\n* No ethnic\u002Fracial groups will be excluded",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":111,"contacts":112,"geoPoint":118},"Brown University Health - Lipid Clinic","Providence","Rhode Island","02914","United States",[113],{"name":114,"role":115,"phone":116,"email":117},"Wenliang Song, MD","CONTACT","267 951 77 59","wsong@brownhealth.org",{"lat":119,"lon":120},41.82399,-71.41283,[122,125],{"name":114,"role":115,"phone":123,"email":124},"4014449851","WSong@Lifespan.org",{"name":126,"role":115,"phone":127,"email":128},"Daria Salamevich","4014449857","DSalamevich@Lifespan.org",[130],{"name":114,"affiliation":131,"role":132},"LIFESPAN CARDIOVASCULAR INSTITUTE","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":136,"biomarkers":138},[20,137],"Lipid Metabolism Disorder",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":150},{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study planning to enroll 80 participants. You will be randomly assigned to receive either EPA or DHA fish oil.","completed","Fish Oil Study for Lipid Metabolism Disorders","This study is looking into how two types of fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), affect blood fats and platelets (tiny blood cells that help form clots) in people with high cholesterol. We want to see if these fish oils have different effects on your body. You might be able to join if you are 18 to 69 years old and have specific levels of triglycerides (a type of fat in your blood) between 150 and 500 mg\u002FdL, and certain HDL-C (good cholesterol) and LDL-C (bad cholesterol) levels. The main goal is to measure how much your platelets clump together after 8 weeks of taking either EPA or DHA. The study is currently unclear on its status and plans to enroll 80 participants.","The primary outcome will be measured at 8 weeks.",126,"You will visit the clinic 3 times for checkups, tests, and blood collection. You will also keep a 28-day food and activity log.","Not stated in the trial record.",[35,41],"v2"]