NCT07036692 The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
| NCT ID | NCT07036692 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Nutritional and Metabolic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-10-09 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 to a scale to self-report weight * Access and willing to use an electronic device (e.g., mobile phone, computer or tablet) * Laboratory assessments of blood parameters were performed within a reasonable timeframe prior to the eligibility assessment, as determined by the PI. 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) * Recent (\<1 month) dose adjustment, initiation or termination of proton pump inhibitors use (e.g., pantoprazole, omeprazole) * 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 bolus insulin therapy or frequent dose adjustments in base line insulin * 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 * Last visit with TP \> 22 days prior to eligibility assessment
Contact & Investigator
Maria L Balmer, Prof. med.
PRINCIPAL INVESTIGATOR
Department of Biomedical Research, University of Bern
Frequently Asked Questions
Who can join the NCT07036692 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, studying Nutritional and Metabolic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07036692 currently recruiting?
Yes, NCT07036692 is actively recruiting participants. Contact the research team at maria.balmer@unibe.ch for enrollment information.
Where is the NCT07036692 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT07036692 clinical trial?
NCT07036692 is sponsored by University of Bern. The principal investigator is Maria L Balmer, Prof. med. at Department of Biomedical Research, University of Bern. The trial plans to enroll 120 participants.