Long-term weight loss using a galactooligosaccharide (GOS) chewing gum
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
This study will see if a chewing gum containing galactooligosaccharides (GOS) helps adults with overweight (BMI >25) lower their weight and change their oral and gut microbiomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07036692 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults aged 25 or older with BMI >25 and at least one metabolic risk factor to test a GOS-containing chewing gum (FibreGum) versus a placebo gum over a long-term period. Participants will regularly report weight, provide blood tests, and collect oral and fecal samples to measure changes in BMI, metabolic markers, and microbiome composition. The protocol requires the ability to chew gum as instructed, collect samples, use an electronic device for reporting, and excludes recent systemic antibiotic use. The study is led by the University of Bern with collaboration from DCB Research AG and is run at the Department of Biomedical Research in Bern.
Who should consider this trial
Good fit: Adults ≥25 years with BMI >25 and at least one metabolic risk factor (for example HbA1c ≥5.7%, elevated liver enzymes, LDL >3.0 mmol/L, or triglycerides >1.7 mmol/L) who can chew gum regularly, collect stool samples, use an electronic device, and have not used systemic antibiotics in the prior 2 months.
Not a fit: People without overweight or metabolic risk, those who used systemic antibiotics within the last 2 months, or those unwilling/unable to comply with gum-chewing and sample collection are unlikely to receive benefit.
Why it matters
Potential benefit: If successful, this could offer a simple, low-threshold tool to help overweight adults reduce BMI and favorably modify oral and gut microbiomes.
How similar studies have performed: Dietary and prebiotic GOS interventions have produced microbiome shifts and modest metabolic effects in prior studies, but delivering GOS via chewing gum is a relatively novel approach with limited direct evidence for weight loss.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- Department of Biomedical Research, University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Maria L Balmer, Prof. med. — Department of Biomedical Research, University of Bern
- Study coordinator: Maria L Balmer, Prof. med.
- Email: maria.balmer@unibe.ch
- Phone: 031 632 26 19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.