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

University of Bern

Status: Enrolling

Conditions: Overweight; Nutritional and Metabolic Diseases

Treatments: Dietary Supplement: Placebo; Dietary Supplement: FibreGum

Study type: Interventional

Funder types: Other

Identifiers

NCT07036692

FaibaGo

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Chewing gum containing maltitol powder

Treatment:

Dietary Supplement: Placebo

Interventional

Experimental group

Description:

Chewing gums containing galactooligosaccharides (GOS)

Treatment:

Dietary Supplement: FibreGum

No-treatment control

No Intervention group

Description:

No chewing-gums