[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595764":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":24,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":49,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Bern","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Chewing gum containing maltitol powder",[13],"Dietary Supplement: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Interventional","EXPERIMENTAL","Chewing gums containing galactooligosaccharides (GOS)",[19],"Dietary Supplement: FibreGum",{"label":21,"type":22,"description":23,"interventionNames":24},"No-treatment control","NO_INTERVENTION","No chewing-gums",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"DIETARY_SUPPLEMENT","To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.",[9],{"type":27,"name":31,"description":28,"armGroupLabels":32,"otherNames":24},"FibreGum",[15],[34],{"name":35,"affiliation":36,"role":37},"Maria L Balmer, Prof. med.","Department of Biomedical Research, University of Bern","PRINCIPAL_INVESTIGATOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","031 632 26 19","0041","maria.balmer@unibe.ch",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Janina N Zünd, PhD","janina.zuend@unibe.ch",[48],{"facility":36,"status":49,"city":50,"state":24,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Bern","3010","Switzerland","CH",{"type":55,"coordinates":56},"Point",[57,58],7.44744,46.94809,{"lat":58,"lon":57},[61],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":63,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[65],{"name":66,"class":6},"DCB Research AG","100595764","the-faibago-study---long-term-weight-reduction-via-low-threshold-intervention-100595764",false,"NCT07036692","The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention","Inclusion Criteria:\n\n* Informed Consent (IC) according to ICH\u002FGCP regulations prior to any study-specific procedures\n* Adults aged ≥ 25 years\n* Overweight as determined by a Body Mass Index \\> 25 kg\u002Fm2\n* Metabolic risk factor: at least one of the following criteria:\n\n  i. HbA1c ≥ 5.7% ii. Elevated liver enzymes (ALAT, ASAT, Gamma-Glutamyltransferase (gGT) at least one above normal range of the assay used in the respective laboratory) iii. LDL-cholesterol \\> 3.0 mmol\u002Fl iv. Triglycerides \\> 1.7 mmol\u002Fl\n* Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)\n* Access to a scale to self-report weight\n* Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)\n* Laboratory assessments of blood parameters were performed within a reasonable timeframe prior to the eligibility assessment, as determined by the PI.\n\nExclusion Criteria:\n\n* Systemic antibiotic use within the last 2 months\n* History of bariatric surgery\n* Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)\n* Use of prebiotic or probiotic supplementation (duration \\>1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)\n* Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)\n* Recent (\\\u003C1 month) dose adjustment, initiation or termination of proton pump inhibitors use (e.g., pantoprazole, omeprazole)\n* Professionally supervised intensive (\\>6 months of ongoing supervision) weight management treatments (e.g., structured nutrition counselling) within the last year (at the PI's discretion)\n* Diagnosis of Type 1 or Type 2 diabetes requiring bolus insulin therapy or frequent dose adjustments in base line insulin\n* Regular alcohol consumption exceeding two (women) or three (men) standard units (10 g of pure alcohol) per day\n* Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month\n* Regular drug abuse (once per week over the past 4 months)\n* Any stage of known pregnancy or lactation period (self-reported)\n* Active cancer or recent cancer treatment (within the last 4 months)\n* Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid arthritis)\n* Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, gastroparesis)\n* Known eating disorder (medically diagnosed)\n* Participation in another investigation with an investigational drug within the 30 days preceding randomisation\n* Dependency from the Sponsor-Investigator\n* Last visit with TP \\> 22 days prior to eligibility assessment","ALL","25 Years",{"count":76,"type":77},120,"ESTIMATED","INTERVENTIONAL",[80],"NA","The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on the body mass index (BMI), the metabolism and the oral and intestinal microbiomes in a population of overweight adults.",[83,84],"Nutritional and Metabolic Diseases","Overweight",[84,86,87,88,89,90],"Chewing gum","Galactooligosaccharides","GOS (Galactooligosaccharides)","Oral microbiome","Intestinal microbiome","2025-11-17",{"date":93,"type":94},"2025-11-21","ACTUAL",{"date":96,"type":94},"2025-10-09",{"date":98,"type":77},"2026-12",{"name":5,"class":6},1]