Placebo: To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
FibreGum: To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Study 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
Sex
ALL
Min age
25 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Change in the Body Mass Index (BMI) during intervention — 4 months Difference in the BMI measured at intervention start and intervention completion
Trial sites (1)
Facility
City
Region
Status
Department of Biomedical Research, University of Bern
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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