The FaibaGo Study - Long-term Weight Reduction through Low-threshold Intervention
Résumé de l'étude
The FaibaGo study is a randomized, placebo-controlled, double-blind intervention study conducted by the University of Bern. It investigates the effectiveness of a fiber-containing chewing gum on weight reduction. After electronic consent, 120 overweight adults (BMI > 25 kg/m²) with a metabolic risk profile will be randomly assigned to one of three study groups. Participants in the intervention group will chew a fiber-containing gum three times a day, those in the placebo group will receive an optically identical gum without fiber, while participants in the control group will receive no intervention. The study duration is six months (four months of intervention, two months of follow-up). The study procedures are largely decentralized: Participants will carry out the intervention independently at home, including the collection of anthropometric data, submission of stool, saliva, and breath samples, as well as completing questionnaires (electronically or on paper). Medical entry examinations will be conducted by the respective attending general practitioner.
(BASEC)
Intervention étudiée
This study aims to show whether chewing a fiber-containing gum for at least 20 minutes, three times a day over a period of 4 months leads to a significant weight loss.
(BASEC)
Maladie en cours d'investigation
The study targets overweight adults with slightly elevated metabolic risk. The aim is to explore new, practical approaches to the prevention and treatment of overweight and its associated diseases.
(BASEC)
• Adults aged 25 and older • Overweight: Body Mass Index (BMI) over 25 kg/m² • At least one metabolic risk factor is present: - Long-term blood sugar level (HbA1c) from 5.7 % - Elevated liver values (ALAT, ASAT or gGT above normal range) - Elevated 'bad' cholesterol (LDL) over 3.0 mmol/l - Elevated blood fat levels (triglycerides) over 1.7 mmol/l • Ability and willingness to participate in the study process (e.g., chewing gum, submitting stool samples) • Access to an electronic device (e.g., smartphone, computer, or tablet) and willingness to use it for the study (BASEC)
Critères d'exclusion
• Intake of antibiotics in the last 2 months • Weight reduction surgery in the past (bariatric surgery) • New or changed medications for high blood fats or high blood sugar • Intake of prebiotics or probiotics • Medical treatments for weight reduction (e.g., GLP-1 medications) • Participation in an intensive, professionally supervised weight loss program in the last year • Diagnosis of Type 1 or Type 2 diabetes requiring insulin • Daily intake of medications to reduce stomach acid (proton pump inhibitors) (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
University of Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Maria Luisa Balmer, MD, PhD
+41 31 632 26 19
maria.balmer@clutterunibe.chDepartment of Biomedical Research, University of Bern
(BASEC)
Informations générales
Department of Biomedical Research, University of Bern
031 632 26 19031 632 26 19
maria.balmer@clutterunibe.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
30.07.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT07036692 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
The FaibaGo Study - Long-Term Weight Reduction via Low-Threshold Intervention (BASEC)
Titre académique
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention (ICTRP)
Titre public
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention (ICTRP)
Maladie en cours d'investigation
Nutritional and Metabolic DiseasesOverweight (ICTRP)
Intervention étudiée
Dietary Supplement: PlaceboDietary Supplement: FibreGum (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific
procedures
- Adults aged = 25 years
- Overweight as determined by a Body Mass Index > 25 kg/m2
- Metabolic risk factor: at least one of the following criteria:
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
- Ability and willingness to follow the study protocol (e.g., cognitive capacity for
compliance, gum chewing, faecal sample collection)
- Access and willing to use an electronic device (e.g., mobile phone, computer or
tablet)
Exclusion Criteria:
- Systemic antibiotic use within the last 2 months
- History of bariatric surgery
- 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)
- Use of prebiotic or probiotic supplementation (duration >1 month) within the last 6
weeks (at PI's discretion, based on medication summary of TP)
- Medical weight management treatments within the last year (e.g., Glucagon-Like
Peptide-1 (GLP-1) agonists)
- Daily use of proton pump inhibitors (e.g., pantoprazole, omeprazole) during time of
study
- 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)
- Diagnosis of Type 1 or Type 2 diabetes requiring insulin therapy
- Regular alcohol consumption exceeding two (women) or three (men) standard units (10
g of pure alcohol) per day
- Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month
- Regular drug abuse (once per week over the past 4 months)
- Any stage of known pregnancy or lactation period (self-reported)
- Active cancer or recent cancer treatment (within the last 4 months)
- Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid
arthritis)
- Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome,
gastroparesis)
- Known eating disorder (medically diagnosed)
- Participation in another investigation with an investigational drug within the 30
days preceding randomisation
- Dependency from the Sponsor-Investigator (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Reduction in the Body Mass Index (BMI) (ICTRP)
Systolic blood pressures change;Diastolic blood pressures changes;Fasting blood glucose change;Fasting insulin change;HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change;Hemoglobin A1c (HbA1c) change;Cholesterol change;Triglyceride change;High-density lipoproteins (HDL) change;Low-density lipoproteins (LDL) change;Neutrophils change;Lymphocytes change;Monocyte change;Eosinophils change;Basophils change;Alanine Aminotransferase (ALAT) change;Aspartate Aminotransferase (ASAT) change;Calcifediol (25OH-Vitamin D3) change;Thyroid-Stimulating Hormone (TSH) change;Ferritin change;Proteinuria change;Oral microbiome change;Gut microbiome change;Breath metabolome change;Body composition change (body fat);Body composition change (lean mass);Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds;Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
DCB Research AG (ICTRP)
Contacts supplémentaires
Maria L Balmer, Prof. med.Maria L Balmer, Prof. med.Maria L Balmer, Prof. med., maria.balmer@unibe.chmaria.balmer@unibe.ch, 031 632 26 19031 632 26 19, Department of Biomedical Research, University of Bern (ICTRP)
ID secondaires
FaibaGo (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT07036692 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible