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

NCT07036692 | Recruiting

• 1 other identifier: FaibaGo
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional and Metabolic Diseases; Overweight

Keywords

Overweight; Chewing gum; Galactooligosaccharides; GOS (Galactooligosaccharides); Oral microbiome; Intestinal microbiome

Outcome Measures

Primary Outcomes (1)

• Change in the Body Mass Index (BMI) during intervention

  Difference in the BMI measured at intervention start and intervention completion

  4 months

Secondary Outcomes (32)

• Systolic blood pressures change during intervention

  4 months

• Diastolic blood pressures changes during intervention

  4 months

• Self-reported weight changes during intervention

  4 months

• Self-reported weight changes during follow-up

  2 months from intervention completion (month 4) to end of follow-up period (month 6)

• Waist circumference changes during intervention

  4 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Chewing gum containing maltitol powder

Dietary Supplement: Placebo

Interventional

EXPERIMENTAL

Chewing gums containing galactooligosaccharides (GOS)

Dietary Supplement: FibreGum

No-treatment control

NO INTERVENTION

No chewing-gums

Interventions

Placebo DIETARY_SUPPLEMENT

To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

Placebo

FibreGum DIETARY_SUPPLEMENT

To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

Interventional

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bern: lead
• DCB Research AG: collaborator

Study Sites (1)

Department of Biomedical Research, University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria L Balmer, Prof. med.

  Department of Biomedical Research, University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L Balmer, Prof. med.

CONTACT

031 632 26 19; maria.balmer@unibe.ch

Janina N Zünd, PhD

CONTACT

031 632 26 19; janina.zuend@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)