The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
Trial Parameters
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 * Histor