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The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention

RecruitingNAAges 25 Years - anyAllUniversity of Bern
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures * Adults aged โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Placebo
  • FibreGum
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Where

1 site
Department of Biomedical Research, University of Bern
Bern, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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