[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100584795","mechanism-of-ketogenic-diet-induced-hypercholesterolemia-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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Hypercholesterolemia and Hyperlipidemia",[29,30,31,32],"LDL-cholesterol","cholesterol","ketogenic diet","lipoprotein kinetics","RECRUITING","2026-03-19",{"date":36,"type":37},"2026-03-23","ACTUAL",{"date":39,"type":37},"2025-02-24",{"date":41,"type":21},"2030-11-30",{"name":43,"class":44},"Washington University School of Medicine","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100578374","evaluation-of-the-effects-of-two-dietary-supplement-formulations-on-the-lipid-profile-in-mild-hypercholesterolemia-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":55,"type":21},99,[24],"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.",[27,59],"Supplementation",[61,62,63,64],"mild hypercholesterolemia","supplement","lipid profile","dietary supplement","2025-01-30",{"date":67,"type":37},"2025-02-05",{"date":69,"type":37},"2024-12-17",{"date":71,"type":21},"2026-01",{"name":73,"class":74},"IBSA Farmaceutici Italia Srl","INDUSTRY"]