[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613224":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":26,"responsibleParty":35,"collaborators":26,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","ACTIVE_COMPARATOR","Patients taking nutraceutical",[13],"Dietary Supplement: GlycoDual",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients taking placebo",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","GlycoDual","GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia",[9],null,{"type":6,"name":15,"description":15,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Giuseppe Derosa, MD","CONTACT","+390382502614","g.derosa@smatteo.pv.it",{"type":36,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Giuseppe Derosa","100613224","effect-of-a-food-supplement-on-glycemic-parameters-in-patients-with-impaired-glucose-metabolism-100613224",false,"NCT07263802","Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism","Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study","Inclusion Criteria:\n\n* body mass index (BMI) 25.0-29.9 kg\u002Fm2\n* FPG levels between 100 and 125 mg\u002Fdl \\[IFG diagnosed after Oral Glucose Tolerance Test (OGTT)\\]\n* HOMA-IR \\> 2.5\n* subjects able to understand the informed consent and sign it before enrollment in the study\n\nExclusion Criteria:\n\n* personal history of cardiovascular disease or equivalent risk factors\n* obesity (BMI ≥ 30 kg\u002Fm²)\n* taking hypoglycemic drugs or supplements that affect glycemic metabolism\n* diabetes mellitus or IGT\n* pregnancy or breastfeeding\n* known thyroid, liver, kidney or muscle diseases\n* any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent\n* any known allergy or hypersensitivity to one or more components of the food supplement","ALL","35 Years","70 Years",{"count":49,"type":50},90,"ESTIMATED","INTERVENTIONAL",[53],"NA","The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.\n\nSecondary objectives are to estimate:\n\n* the change of insulin sensitivity (HOMA-IR)\n* the change of uricemia after 90 days of supplementation compared to placebo.\n\nSafety objectives: Collection of the adverse events not related, related or possibly related to the study products.",[56,57],"Impaired Fasting Glucose (IFG)","Impaired Glucose Tolerance (Prediabetes)",[59,60,61],"dysglycemia","Gymnema sylvestre","Zinc bisglycinate","NOT_YET_RECRUITING","2025-11-23",{"date":65,"type":66},"2025-12-04","ACTUAL",{"date":68,"type":50},"2025-12-01",{"date":70,"type":50},"2026-02-28",{"name":5,"class":6}]