FaibaLite - Reduce Weight, One Bite at a Time

This study aims to evaluate the suitability of a fiber-enriched chewing gum as a practical and accessible approach to support healthy body weight management.

Study Overview

• Status: Withdrawn
• Conditions: Nutritional and Metabolic Diseases
• Intervention / Treatment: Dietary supplement: FibreGum chewing gum

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of Biomedical Research, University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written Informed Consent
• Healthy adults aged 18 to 65 years (inclusive), as determined by the investigator
• BMI of 23 to 40 kg/m2 (inclusive)
• Living in Switzerland
• Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing)
• Access and willingness to use an electronic device (e.g., mobile phone, computer or tablet)
• Access to a scale to self-report weight

Exclusion Criteria:

• Current weight loss therapy with Glucagon-like Peptide 1 (GLP-1) agonists or other non-prescription products (at investigator's discretion)
• Treatment with a GLP-1 agonist within the past 2 months
• Initiation/Discontinuation of nicotine product use (>1 nicotine product per day, e.g., (e-)cigarette, gum) within the last 2 months (at investigator's discretion)
• Significant change in medication within the last 2 months (at investigator's discretion)
• Unable to chew gum 3 times daily (e.g. due to dental issues, at investigator's discretion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FibreGum Intervention Group; Participants chew one fiber-containing gum (FibreGum) three times daily (morning, noon, and evening) for at least 20 minutes each, over two months, with the option to extend the intervention to three months.	Dietary supplement: FibreGum chewing gum; Chewing gum containing galactooligosaccharides (GOS), delivering a total daily dose of 3 g of dietary fiber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate	Feasibility will be assessed as a composite endpoint including the following parameters among healthy adults: Participant adherence rate (percentage of recommended chewing performed); User acceptance score (based on questionnaire); Dropout rate (percentage of participants who discontinue the study prematurely)	Up to 3 months (end of chewing phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of intervention	Duration of the study intervention, e.g. the willingness to continue FibreGum consumption for an additional month after 2 months of intervention	Up to 3 months after study start
Reduction in body weight (%)	Reduction in percent of body weight between baseline and end of intervention	2 or 3 months
Change in body composition (body fat)	Difference in body fat* (if available) between baseline and end of intervention *This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment	2 or 3 months
Change in body composition (lean mass)	Difference in lean mass* (if available) between baseline and end of intervention *This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment	2 or 3 months
Change in body composition (muscle mass)	Difference in muscle mass* (if available) between baseline and end of intervention *This read-out is voluntary for participants willing to come to the investigational site according to Table of Assessment	2 or 3 months
Change in gut microbiota alpha-diversity	Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics	2 months
Change in gut microbiota beta-diversity	Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics	2 months
Change in differential abundance of gut microbiota	Change in the relative abundance of specific bacterial taxa between baseline and timepoint 2, assessed by metagenomic sequencing	2 months
Changes in body weight during follow-up	Changes in body weight from completion of intervention to end of study	1 or 2 months

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: DCB Research AG
• Investigators: Principal Investigator: Maria L Balmer, Prof. med., Department of Biomedical Research, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): April 13, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): July 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Gut microbiota; Chewing gum; Intestinal microbiome; Galactooligosaccharides; GOS (Galactooligosaccharides)
• Additional Relevant MeSH Terms: Nutritional and Metabolic Diseases
• Other Study ID Numbers: FaibaLite

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No