[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypercholesterolemia-and-hyperlipidemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypercholesterolemia-and-hyperlipidemia":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":14,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100584795",false,"NCT06894004","Mechanism of Ketogenic Diet-Induced Hypercholesterolemia","Inclusion Criteria:\n\n1. age ≥ 18 and \\\u003C 40 years\n2. BMI ≥ 18.5 and \\\u003C 25.0 kg\u002Fm2\n3. baseline serum LDL-c \\\u003C 150 mg\u002FdL (\\\u003C 3.9 mmol\u002FL)\n4. baseline serum TG \\\u003C 100 mg\u002FdL (\\\u003C 1.1 mmol\u002FL)\n5. HbA1c ≤ 5.6%.\n\nExclusion Criteria:\n\n1. personal or family history of familial hypercholesterolemia\n2. current use of lipid-lowering drugs\n3. currently on a ketogenic diet and unwilling to change diet\n4. current tobacco use\n5. hypertension\n6. prediabetes or diabetes\n7. elevated Lp(a) \\> 6.5% of ApoB-containing lipoproteins at baseline\n8. oral contraceptive use\n9. contraindication to heparin\n10. known atherosclerotic cardiovascular disease\n11. unwilling to abstain from alcohol",true,"ALL","18 Years","39 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify \"responders\" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.",[26],"Hypercholesterolemia and Hyperlipidemia",[28,29,30,31],"LDL-cholesterol","cholesterol","ketogenic diet","lipoprotein kinetics","RECRUITING","2026-03-19",{"date":35,"type":36},"2026-03-23","ACTUAL",{"date":38,"type":36},"2025-02-24",{"date":40,"type":20},"2030-11-30",{"name":42,"class":43},"Washington University School of Medicine","OTHER",1,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":44},"100578374","NCT06810466","Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia","A Single-blind, Parallel-group, Randomized, Placebo-controlled Clinical Trial, to Evaluate the Effects of Two Different Formulations of a Dietary Supplement on the Lipid Profile in Subjects with Mild Hypercholesterolemia","Inclusion Criteria:\n\n* Prevention of cardiovascular disease\n* Low cardiovascular risk (\\\u003C 5%)\n* Sub-optimal serum levels of LDL-C (130-136 mg\u002Fdl; 3.37-4.14 mmol\u002Fl) and\u002For non-HDL-C (160-190 mg\u002Fdl; 4.14-4.92 mmol\u002Fl) at T-2\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \\>\u002F= 5)\n* diabetes mellitus\n* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism\n* Hypertension treatment not stabilized for at least 3 months\n* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease\n* Any medical-surgical treatment that may limit adherence to the study protocol\n* Pregnant and\u002For breastfeeding women","69 Years",{"count":53,"type":20},99,[23],"A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.\n\nThe study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:\n\nGroup A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo\n\nThe following visits are scheduled during the study:\n\nT-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.",[26,57],"Supplementation",[59,60,61,62],"mild hypercholesterolemia","supplement","lipid profile","dietary supplement","2025-01-30",{"date":65,"type":36},"2025-02-05",{"date":67,"type":36},"2024-12-17",{"date":69,"type":20},"2026-01",{"name":71,"class":72},"IBSA Farmaceutici Italia Srl","INDUSTRY",""]