Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-27 @ 11:58 AM
Study NCT ID:
NCT07036692
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Body Mass Index (BMI) during intervention', 'timeFrame': '4 months', 'description': 'Difference in the BMI measured at intervention start and intervention completion'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressures change during intervention', 'timeFrame': '4 months', 'description': 'Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start.'}, {'measure': 'Diastolic blood pressures changes during intervention', 'timeFrame': '4 months', 'description': 'Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.'}, {'measure': 'Self-reported weight changes during intervention', 'timeFrame': '4 months', 'description': 'Difference in self-reported weight (kg) between intervention completion and intervention start.'}, {'measure': 'Self-reported weight changes during follow-up', 'timeFrame': '2 months from intervention completion (month 4) to end of follow-up period (month 6)', 'description': 'Difference in self-reported weight (kg) between end of follow-up period and intervention completion.'}, {'measure': 'Waist circumference changes during intervention', 'timeFrame': '4 months', 'description': 'Difference in waist circumference (cm) between between intervention completion and intervention start.'}, {'measure': 'Waist circumference changes during follow-up', 'timeFrame': '2 months from intervention completion (month 4) to end of follow-up period (month 6)', 'description': 'Difference in waist circumference (cm) between end of follow-up period and intervention completion.'}, {'measure': 'Fasting blood glucose change during intervention', 'timeFrame': '4 months', 'description': 'Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start.'}, {'measure': 'Fasting insulin change during intervention', 'timeFrame': '4 months', 'description': 'Difference in fasting insulin (mIU/mL) between intervention completion and intervention start.'}, {'measure': 'HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between intervention completion and intervention start. Lower scores mean better outcome.'}, {'measure': 'Hemoglobin A1c (HbA1c) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in HbA1c (mmol/mol) between intervention completion and intervention start.'}, {'measure': 'Cholesterol change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Cholesterol (mg/dL) between intervention completion and intervention start.'}, {'measure': 'Triglyceride change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Triglyceride (mg/dL) between intervention completion and intervention start.'}, {'measure': 'High-density lipoproteins (HDL) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in HDL (mg/dL) between intervention completion and intervention start.'}, {'measure': 'Low-density lipoproteins (LDL) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in LDL (mg/dL) between intervention completion and intervention start.'}, {'measure': 'Neutrophils change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Neutrophils count (%) between intervention completion and intervention start.'}, {'measure': 'Lymphocytes change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Lymphocytes count (%) between intervention completion and intervention start.'}, {'measure': 'Monocyte change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Monocytes count (%) between intervention completion and intervention start.'}, {'measure': 'Eosinophils change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Eosinophils count (%) between intervention completion and intervention start.'}, {'measure': 'Basophils change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Basophils count (%) between intervention completion and intervention start.'}, {'measure': 'Alanine Aminotransferase (ALAT) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in ALAT (U/L) between intervention completion and intervention start.'}, {'measure': 'Aspartate Aminotransferase (ASAT) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in ASAT (U/L) between intervention completion and intervention start.'}, {'measure': 'Calcifediol (25OH-Vitamin D3) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Calcifediol (nmol/L) between intervention completion and intervention start.'}, {'measure': 'Thyroid-Stimulating Hormone (TSH) change during intervention', 'timeFrame': '4 months', 'description': 'Difference in TSH (mU/L) between intervention completion and intervention start.'}, {'measure': 'Ferritin change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Ferritin (μg/L) between intervention completion and intervention start.'}, {'measure': 'Proteinuria change during intervention', 'timeFrame': '4 months', 'description': 'Difference in Proteinuria (g/24h) between intervention completion and intervention start.'}, {'measure': 'Oral microbiome change during intervention', 'timeFrame': '4 months', 'description': 'Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start.'}, {'measure': 'Gut microbiome change during intervention', 'timeFrame': '4 months', 'description': 'Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start.'}, {'measure': 'Breath metabolome change during intervention', 'timeFrame': '4 months', 'description': 'Change in volatile compounds present in the breath detected by secondary electrospray ionization (SESI) source in combination with a high-resolution mass spectrometry (HR-MS) between intervention completion and intervention start.'}, {'measure': 'Body composition change (body fat) during intervention', 'timeFrame': '4 months', 'description': 'Change in body fat between intervention completion and intervention start.'}, {'measure': 'Body composition change (lean mass) during intervention', 'timeFrame': '4 months', 'description': 'Change in lean mass between intervention completion and intervention start.'}, {'measure': 'Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds during intervention', 'timeFrame': '4 months', 'description': 'Change in community diversity (alpha diversity) assessed by metagenomic sequencing between intervention completion and intervention start.'}, {'measure': 'Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds during intervention', 'timeFrame': '4 months', 'description': 'Change in composition (beta diversity, differential abundance) assessed by metagenomic sequencing between intervention completion and intervention start.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Chewing gum', 'Galactooligosaccharides', 'GOS (Galactooligosaccharides)', 'Oral microbiome', 'Intestinal microbiome'], 'conditions': ['Nutritional and Metabolic Diseases', 'Overweight']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures\n* Adults aged ≥ 25 years\n* Overweight as determined by a Body Mass Index \\> 25 kg/m2\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/l iv. Triglycerides \\> 1.7 mmol/l\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 (\\<1 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"}, 'identificationModule': {'nctId': 'NCT07036692', 'briefTitle': 'The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention', 'orgStudyIdInfo': {'id': 'FaibaGo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Chewing gum containing maltitol powder', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Chewing gums containing galactooligosaccharides (GOS)', 'interventionNames': ['Dietary Supplement: FibreGum']}, {'type': 'NO_INTERVENTION', 'label': 'No-treatment control', 'description': 'No chewing-gums'}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.', 'armGroupLabels': ['Placebo']}, {'name': 'FibreGum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'CONTACT', 'email': 'maria.balmer@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}], 'facility': 'Department of Biomedical Research, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'CONTACT', 'email': 'maria.balmer@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}, {'name': 'Janina N Zünd, PhD', 'role': 'CONTACT', 'email': 'janina.zuend@unibe.ch', 'phone': '031 632 26 19', 'phoneExt': '0041'}], 'overallOfficials': [{'name': 'Maria L Balmer, Prof. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Research, University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'DCB Research AG', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}