[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632583":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":57,"slug":26,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"U.G.A. Nutraceuticals","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Weeks 0-8: double-blind phase; placebo, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.",[13,14],"Dietary Supplement: Cardiol Forte","Other: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Dietary supplement - Cardiol Forte","EXPERIMENTAL","Weeks 0-8: double-blind phase; Cardiol Forte, 2 capsules orally once daily. Weeks 8-16: open-label phase; Cardiol Forte, 2 capsules orally once daily.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Cardiol Forte","Each capsule of Cardiol Forte contains fish oil 5025 TG 550.488 mg, corresponding to total omega-3 fatty acids 456 mg, of which eicosapentaenoic acid (EPA) 275 mg and docosahexaenoic acid (DHA) 137 mg; artichoke extract leaves (Altilix®) 150 mg; Citrus bergamia Risso et Poit. dry extract (BPF®) 100 mg; Cynara scolymus L. dry extract 10 mg; olive fruit dry extract standardized to 9% hydroxytyrosol 55.600 mg, corresponding to hydroxytyrosol 5.004 mg; coenzyme Q10 10 mg; folic acid 0.3 mg; and vitamin E 12 mg.",[16,9],null,{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":26},"OTHER","Matching placebo soft capsules are identical to Cardiol Forte in appearance, odour, and taste and contain no active ingredients.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Arrigo Francesco Giuseppe Cicero, MD, PhD","CONTACT","+39051214290","arrigo.cicero@unibo.it",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cardiovascular Internal Medicine Unit, IRCCS University Hospital of Bologna, Bologna, Italy","Bologna","BO","40100","Italy",{"type":45,"coordinates":46},"Point",[47,48],11.33875,44.49381,{"lat":48,"lon":47},[51,52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":53,"role":54,"phone":26,"phoneExt":26,"email":26},"Valentina Di Micoli, BD","SUB_INVESTIGATOR",{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100632583",false,"NCT07515573","Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals","A Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group Clinical Trial With an Open-Label Extension to Evaluate the Effects of a Combination Dietary Supplement (Cardiol Forte) on Lipid and Glycemic Parameters in Subjects at Low Cardiovascular Risk With Suboptimal Cholesterol Levels","CLARISKI","Inclusion Criteria:\n\n* Male or female aged 18 to 79 years\n* Individuals in primary cardiovascular prevention\n* Estimated 10-year cardiovascular risk \\\u003C10%\n* Screening non-HDL-C between 140 and 220 mg\u002FdL, or screening LDL-C between 110 and 190 mg\u002FdL\n* Ability to communicate adequately, to be understood, and to comply with the study requirements\n* Willingness to participate in the study and provision of written, signed, and dated informed consent\n\nExclusion Criteria:\n\n* Triglycerides \\>400 mg\u002FdL at screening\n* Type 1 or type 2 diabetes mellitus\n* Body mass index \\>35 kg\u002Fm²\n* Current treatment with lipid-lowering drugs or use of dietary supplements active on lipid metabolism\n* Antihypertensive treatment not stabilized for at least 3 months\n* Known clinically significant alterations of thyroid, hepatic, and\u002For renal function\n* Women of childbearing potential not using adequate contraceptive methods\n* Pregnancy or breastfeeding\n* Any medical or surgical condition that, in the investigator's judgment, could make adherence to the protocol difficult or inconsistent, compromise participant safety, or interfere with study completion\n* Known intolerance or hypersensitivity to any component of the study products","ALL","18 Years","79 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, Omega-3 Index, selected inflammatory and liver-related markers, and endothelial reactivity.",[75],"Dyslipidemia",[23,75,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"non-HDL cholesterol","Glycemic profile","Cardiovascular prevention","Low cardiovascular risk","Eicosapentaenoic acid","EPA","Docosahexaenoic acid","DHA","Artichoke","Bergamot","Hydroxytyrosol","Coenzyme Q10","Folic acid","Vitamin E","NOT_YET_RECRUITING","2026-04-15",{"date":94,"type":95},"2026-04-20","ACTUAL",{"date":97,"type":69},"2026-05-04",{"date":99,"type":69},"2028-05-04",{"name":5,"class":6},1]