The FaibaGo Study - Long-term Weight Reduction through Low-threshold Intervention
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Bern
(BASEC)
Sponsor
University of Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Maria Luisa Balmer, MD, PhD
+41 31 632 26 19
maria.balmer@clutterunibe.chDepartment of Biomedical Research, University of Bern
(BASEC)
Allgemeine Auskünfte
Department of Biomedical Research, University of Bern
031 632 26 19031 632 26 19
maria.balmer@clutterunibe.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.07.2025
(BASEC)
ICTRP Studien-ID
NCT07036692 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The FaibaGo Study - Long-Term Weight Reduction via Low-Threshold Intervention (BASEC)
Wissenschaftlicher Titel
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention (ICTRP)
Öffentlicher Titel
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention (ICTRP)
Untersuchte Krankheit(en)
Nutritional and Metabolic DiseasesOverweight (ICTRP)
Untersuchte Intervention
Dietary Supplement: PlaceboDietary Supplement: FibreGum (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
DCB Research AG (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
FaibaGo (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT07036692 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar