[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476189":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oligofructose Inulin Supplementation","EXPERIMENTAL","The intervention group will receive a daily fibre supplementation of (fructo-oligosaccharide enriched inulin, 4g twice daily; Orafti®Synergy1, BENEO), a tasteless white powder contained within a tear-able, partitioned 4g sachet, sprinkled and dissolved in 125 mL of water.",[13],"Dietary Supplement: Fructo-oligosaccharide enriched inulin supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Maltodextrin Supplementation","SHAM_COMPARATOR","The control group will receive a daily supplementation of carbohydrate placebo (isocaloric maltodextrin), identical in colour, packaging, preparation, and dose (4g, twice daily; C\\*Dry MD™,Cargill).",[19],"Other: Maltodextrin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Fructo-oligosaccharide enriched inulin supplement","Experiment",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Maltodextrin","Placebo.",[15],[32],{"name":33,"affiliation":5,"role":34},"Nikhil Pai, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Paige AL Cheveldayoff, BSC","CONTACT","3063611281","cheveldp@mcmaster.ca",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":43},"2892082457","pain@mcmaster.ca",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"McMaster University Medical Center","RECRUITING","Hamilton","Ontario","L8S4K1","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-79.84963,43.25011,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":40},"Paige Cheveldayoff, BSc","306-361-1281",{"name":33,"role":38,"phone":64,"phoneExt":65,"email":43},"905.521.2100","73587",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100476189","phase-2-soluble-fibre-supplementation-in-nafld-100476189",false,"NCT05480696","Soluble Fibre Supplementation in NAFLD","The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)","FIND","Inclusion Criteria:\n\n* Children ages 8-17 years\n* Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)\n* Enrolled in GHWM Clinic\n* Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) \\[ALT\\>80 IU\u002FL for 8-17 years of age\\], and hepatic steatosis measured as part of clinic enrolment).\n\nExclusion Criteria:\n\n* Type 1, Type 2 diabetes mellitus (T1DM, T2DM)\n* Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \\> 300lbs)\n* Concomitant use of other fibre supplements\n* Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)\n* Presence of another known cause of liver disease\n* Known allergy or hypersensitivity to OF-INU supplementation\n* Self-reported alcohol intake \\>7 drinks\u002Fweek or 3 drinks\u002Fday","ALL","8 Years","17 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.",[87,88,89],"Non-Alcoholic Fatty Liver Disease","Non Alcoholic Steatohepatitis","Hepatic Steatosis","2024-11-08",{"date":92,"type":93},"2024-11-12","ACTUAL",{"date":95,"type":93},"2022-09-09",{"date":97,"type":81},"2027-03",{"name":5,"class":6},1]