[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526312":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":16,"studyPopulation":16,"armGroups":54,"interventions":67,"overallOfficials":16,"centralContacts":76,"locations":82,"responsibleParty":102,"collaborators":16,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":16,"eligibilityCriteria":111,"healthyVolunteers":108,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":16,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":85,"whyStopped":16,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Change in liver disease severity","Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.","12 weeks",[14,17,19,21,23,25,27,29,31,33,35,37,39,41,43],{"measure":15,"description":16,"timeFrame":12},"Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])",null,{"measure":18,"description":16,"timeFrame":12},"Change in gamma glutamyl-transferase levels (GGT)",{"measure":20,"description":16,"timeFrame":12},"Change in alkaline phosphatase (ALP)",{"measure":22,"description":16,"timeFrame":12},"Change in fasting triglycerides",{"measure":24,"description":16,"timeFrame":12},"Change in total cholesterol (TC)",{"measure":26,"description":16,"timeFrame":12},"Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels",{"measure":28,"description":16,"timeFrame":12},"Change in glucose",{"measure":30,"description":16,"timeFrame":12},"Change in insulin",{"measure":32,"description":16,"timeFrame":12},"Change in glycated hemoglobin (HbA1c)",{"measure":34,"description":16,"timeFrame":12},"Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels",{"measure":36,"description":16,"timeFrame":12},"Change in thyroid function (TSH and Free T4)",{"measure":38,"description":16,"timeFrame":12},"Change in estradiol",{"measure":40,"description":16,"timeFrame":12},"Change in serum metabolome and lipidome",{"measure":42,"description":16,"timeFrame":12},"Change in systolic and diastolic blood pressure",{"measure":44,"description":16,"timeFrame":12},"Change in equol production status",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":16,"timePerspective":16,"maskingInfo":50},"RANDOMIZED","PARALLEL","Prospective parallel arm randomized controlled study","TREATMENT",{"masking":51,"maskingDescription":16,"whoMasked":52},"SINGLE",[53],"INVESTIGATOR",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"2% Fat Cows Milk","PLACEBO_COMPARATOR","Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.",[60],"Drug: 2% Fat Cow's Milk",{"label":62,"type":63,"description":64,"interventionNames":65},"Standard Soy Milk","EXPERIMENTAL","Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.",[66],"Drug: Standard Soy Milk",[68,72],{"type":69,"name":62,"description":70,"armGroupLabels":71,"otherNames":16},"DRUG","Consumption of commercially available soy milk",[62],{"type":69,"name":73,"description":74,"armGroupLabels":75,"otherNames":16},"2% Fat Cow's Milk","Consumption of commercially available 2% cow's milk",[56],[77],{"name":78,"role":79,"phone":80,"phoneExt":16,"email":81},"Ann Popelar","CONTACT","(513) 636-8867","Ann.Popelar@cchmc.org",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Cincinnati Children's Hospital Medical Center","RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-84.51439,39.12711,{"lat":95,"lon":94},[98,99],{"name":78,"role":79,"phone":80,"phoneExt":16,"email":81},{"name":100,"role":101,"phone":16,"phoneExt":16,"email":16},"Marialena Mouzaki, MD","PRINCIPAL_INVESTIGATOR",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"SPONSOR_INVESTIGATOR","Marialena Mouzaki","Professor, Division of Gastroenterology, Hepatology and Nutrition","100526312","phase-2-impact-of-soymilk-on-liver-disease-severity-of-children-with-non-alcoholic-fatty-liver-disease-nafld-100526312",false,"NCT06133101","Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n* Children with overweight\u002Fobesity\n* Known NAFLD or elevated ALT (\\>30)\n\nExclusion Criteria:\n\n* Baseline habitual (\\>3 days per week) consumption of soy foods\n* Allergy to soy or cow's milk protein\n* Inability to undergo MRI\n* Recent (past 8 weeks) antibiotic exposure\n* Treatment for existing endocrine disorders\n* MRI PDFF \\\u003C10%","ALL","5 Years","16 Years",{"count":116,"type":117},44,"ESTIMATED","INTERVENTIONAL",[120],"PHASE2","A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.",[123],"Non-Alcoholic Fatty Liver Disease",[125],"NAFLD","2026-09-18",{"date":128,"type":129},"2026-09-22","ACTUAL",{"date":131,"type":129},"2024-01-15",{"date":133,"type":117},"2028-09",{"name":104,"class":6},1]