Long-term weight loss using a galactooligosaccharide (GOS) chewing gum

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.