[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hdl-cholesterol\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hdl-cholesterol":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100649238","fish-oil-and-hdl-function-in-patients-on-maintenance-hemodialysis-100649238",false,"NCT07730385","Fish Oil and HDL Function in Patients on Maintenance Hemodialysis","Mechanistic Effects of n-3 Polyunsaturated Fatty Acid Supplementation on HDL Function in Patients Receiving Maintenance Hemodialysis (EFFLUX-HD): Study Protocol for a Randomized, Open-label, Crossover Trial","EFFLUX-HD","Inclusion Criteria:\n\n* age ≥ 18 years\n* receiving maintenance in-center hemodialysis\n* able to provide written informed consent\n* clinically stable condition (no hospitalization within 4 weeks prior to baseline)\n\nExclusion Criteria:\n\n* inability or unwillingness to provide informed consent\n* known hypersensitivity or intolerance to fish oil or n-3 PUFA-containing products\n* use of n-3 PUFA supplements at baseline or within the preceding 8 weeks\n* pregnancy\n* acute infection, hospitalization or major inflammatory condition at the time of baseline assessment\n* any condition that, in the investigator's opinion, would make participation unsafe or interfere with study participation or data interpretation\n* inherited lipid metabolism disorders","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. A recent clinical trial (PISCES) found that high-dose omega-3 fatty acids (fish oil) reduced cardiovascular events in hemodialysis patients, but the reason for this benefit is not understood.\n\nOne possible explanation is that, in kidney failure, high-density lipoprotein (HDL) no longer works normally. This study investigates whether omega-3 fatty acid supplementation improves the function of HDL in people on maintenance hemodialysis.\n\nForty adults on maintenance hemodialysis will take part. Each participant receives fish oil (4 g per day) for 8 weeks and also has an 8-week period without supplementation; participants are randomly assigned to the order of these two periods (crossover design), for a total of 16 weeks each. The main measure is cholesterol efflux capacity, a laboratory test of how well HDL removes cholesterol from cells. The study also examines other markers of HDL quality.\n\nThis is an exploratory, mechanistic study. Its aim is to determine whether omega-3 fatty acids change HDL function and to inform the design of larger future trials.",[27,28,29],"Kidney Failure Chronic","Cardiovascular Disease","HDL Cholesterol","NOT_YET_RECRUITING","2026-08-03",{"date":33,"type":34},"2026-08-04","ACTUAL",{"date":36,"type":21},"2026-10",{"date":38,"type":21},"2027-02",{"name":40,"class":41},"Medical University of Vienna","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":42},"100592056","pilot-study-of-bottarga-supplementation-a-little-known-sustainable-blue-food-100592056","NCT06988462","Pilot Study of \"Bottarga\" Supplementation: A Little-known, Sustainable \"Blue\" Food","* Adults aged 18-60 years\n* Residents of Massachusetts\n* Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes\n* Not pregnant\n* Willing to consume a nutritional supplement and comply with study procedures\n\nExclusion Criteria:\n\n* Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression\n* Current use of any supplements containing n-3 fatty acids\n* Current use of illicit drugs (other than marijuana)\n* Use of hormone therapy (except oral contraceptives)\n* Known allergies to fish, seafood, or any fish-derived products, including bottarga\n* Pregnancy\n* Clinical evidence or history of hepatic or renal insufficiency\n* Immunodeficiency conditions\n* History of non-skin cancer\n* Participation in other clinical research studies","60 Years",{"count":51,"type":21},20,[24],"This pilot study aims to explore the potential benefits of consuming Greek bottarga (grey mullet fish roe) in individuals with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes.\n\nBefore initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this phase, the investigators will proceed with a randomized, controlled crossover trial involving 20 eligible adult participants. This main study phase will compare the metabolic effects of daily bottarga supplementation with those of a calorically matched dairy product over an 8-week intervention period, with a 2-week washout period between interventions.\n\nThe investigators anticipate that bottarga supplementation will improve lipid profiles, inflammation markers, and insulin resistance, thereby supporting the potential use of sustainable blue foods as part of a healthy diet.",[55,56,57,58,59,29],"Prediabetes","Diabetes","High Cholesterol\u002FHyperlipidemia","Obesity & Overweight","Triglycerides",[61,62,63,64,65,66,67,68,69],"Bottarga","pre diabetes","inflammation","sustainability","nutritional intervention","overweight","metabolic abnormalities","lipid profile","diabetes","RECRUITING","2026-07-15",{"date":73,"type":34},"2026-07-16",{"date":75,"type":34},"2025-10-17",{"date":77,"type":21},"2027-03-01",{"name":79,"class":41},"Cambridge Health Alliance"]