The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention (NCT07036692) | Clinical Trial Compass
RecruitingNot Applicable
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
Switzerland120 participantsStarted 2025-10-09
Plain-language 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.
Who can participate
Age range25 Years
SexALL
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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 adj…
What they're measuring
1
Change in the Body Mass Index (BMI) during intervention