The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Bern
About this trial
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
Qualifiers
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
Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Placebo
- FibreGum
Treatment groups
120 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Bern
Lead sponsor
DCB Research AG
Collaborator
Source ClinicalTrials.gov