[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631791":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":41,"collaborators":43,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Dr. Schär AG \u002F SPA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-post design","EXPERIMENTAL","Standard diet for 8 weeks, followed by the introduction of functional foods for an additional 8 weeks",[13],"Other: Mediterranean diet and Mediterranean diet + functional foods",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Mediterranean diet and Mediterranean diet + functional foods","1. PHASE: Mediterranean diet for 8 weeks\n2. PHASE: Mediterranean diet + functional foods for 8 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Prof. Lucio Lucchin","CONTACT","+39 0471 442700","veronica.marin@drschaer.com",[28],{"facility":29,"status":30,"city":31,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"Bonvicini Clinic","RECRUITING","Bolzano","39100","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],11.33982,46.49067,{"lat":39,"lon":38},{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[44],{"name":29,"class":45},"UNKNOWN","100631791","study-of-the-effects-of-food-formulations-containing-antioxidants-prebiotic-fibers-and-oat-beta-glucans-in-individuals-at-risk-of-metabolic-syndrome-100631791",false,"NCT07505277","Study of the Effects of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome","Single-arm, Pre-Post Clinical Trial on the Effect of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome.","Inclusion Criteria:\n\n* Age between 18 and 60 years\n* Individuals who do not have metabolic syndrome\n* Presence of abdominal circumference \\>94 cm for men or \\>80 cm for women, or a body mass index (BMI) between 25 and 34.9 kg\u002Fm², and at least two of the following parameters:\n* Impaired glucose tolerance (IGT) (≥100 mg\u002FdL), or borderline hypertension (systolic 120-139 mmHg, diastolic 80-90 mmHg), or mild hypercholesterolemia (200-239 mg\u002FdL)\n* Absence of any long-term pharmacological treatment for diabetes, hypertension, dyslipidemia, hyperuricemia, or other chronic conditions\n\nExclusion Criteria:\n\n* Individuals with metabolic syndrome\n* Continuous pharmacological treatments for dysmetabolic conditions\n* BMI \\\u003C18.5 kg\u002Fm² or \\>35 kg\u002Fm²\n* Glycated hemoglobin (HbA1c) \\> 6%\n* Pregnancy","ALL","18 Years","60 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"NA","The goal of this clinical trial is to evaluate whether introducing specific functional foods into the diet of individuals at risk of developing metabolic syndrome leads to improvements in key metabolic and oxidative health parameters.\n\nThe main questions it aims to answer are:\n\nDoes the consumption of these functional foods reduce post-prandial glycemia? Does daily intake of these formulations improve other health indicators such as body weight, body composition, lipid profile, and oxidative metabolomic markers?\n\nThe functional food formulations used in this study include:\n\nA blend of multifunctional ingredients derived from apple and grape by-products Added prebiotic fibers (inulin) Oat β-glucans Omega-3 fatty acids\n\nParticipants will:\n\nConsume the assigned functional food formulations daily Attend regular clinic visits for physiological measurements and blood tests Undergo assessments of body composition, serum lipids, and serum metabolomics\n\nPrimary Study Objective:\n\nVariation in post-prandial glycemia\n\nSecondary Objectives:\n\nReduction in BMI Changes in body composition Changes in serum lipid profile Changes in serum oxidative-related metabolomics",[64],"Metabolic Syndrome",[64,66,67],"Functional foods","Nutritional intervantion","2026-03-26",{"date":70,"type":71},"2026-04-01","ACTUAL",{"date":73,"type":71},"2026-02-01",{"date":75,"type":58},"2027-06",{"name":5,"class":6},1]