[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578374":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":46,"whyStopped":30,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"IBSA Farmaceutici Italia Srl","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Product A","EXPERIMENTAL","Innovative formulation of dietary supplement",[13],"Dietary Supplement: Test Product A",{"label":15,"type":16,"description":17,"interventionNames":18},"Test Product B","ACTIVE_COMPARATOR","Classic formulation of dietary supplement",[19],"Dietary Supplement: Test Product B",{"label":21,"type":22,"description":21,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR",[24],"Dietary Supplement: Placebo",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Innovative formulation of a dietary supplement for mild hypercholesterolemia. Test Product A will be admistered daily for 8 weeks. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Classic formulation of a dietary supplement for mild hypercholesterolemia. After the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.",[15],{"type":27,"name":21,"description":35,"armGroupLabels":36,"otherNames":30},"Placebo does not contain functional components and is indistinguishable from Product Test B.\n\nAfter the fist 8 weeks, this arm will continue with the intake of the Product Test A for other 8 weeks.",[21],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Arrigo Francesco Giuseppe Cicero, Prof.","CONTACT","+39 512142224","arrigo.cicero@unibo.it",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":48,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"S. Orsola-Malpighi University Hospital","RECRUITING","Bologna","Italy","40138","IT",{"type":52,"coordinates":53},"Point",[54,55],11.33875,44.49381,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":41,"phoneExt":30,"email":42},"Arrigo F.G. Cicero, Prof.",{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[63],{"name":64,"class":65},"Informapro Srl","OTHER","100578374","evaluation-of-the-effects-of-two-dietary-supplement-formulations-on-the-lipid-profile-in-mild-hypercholesterolemia-100578374",false,"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","ALL","18 Years","69 Years",{"count":77,"type":78},99,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84,85],"Hypercholesterolemia and Hyperlipidemia","Supplementation",[87,88,89,90],"mild hypercholesterolemia","supplement","lipid profile","dietary supplement","2025-01-30",{"date":93,"type":94},"2025-02-05","ACTUAL",{"date":96,"type":94},"2024-12-17",{"date":98,"type":78},"2026-01",{"name":5,"class":6},1]