FaibaLite - Reduce Weight, One Bite at a Time

Not Applicable

Not yet recruiting

• Conditions: Nutritional and Metabolic Diseases

• Registration Number: NCT07045766
• Lead Sponsor: University of Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study Start: 2025-07-01
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-02
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate	Up to 3 months (end of chewing phase)	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)

Secondary Outcome Measures

Name	Time	Method
Reduction in body weight (%)	2 or 3 months	Reduction in percent of body weight between baseline and end of intervention
Change in body composition (muscle mass)	2 or 3 months	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
Change in differential abundance of gut microbiota	2 months	Change in the relative abundance of specific bacterial taxa between baseline and timepoint 2, assessed by metagenomic sequencing
Change in gut microbiota beta-diversity	2 months	Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics
Changes in body weight during follow-up	1 or 2 months	Changes in body weight from completion of intervention to end of study
Change in body composition (body fat)	2 or 3 months	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
Change in body composition (lean mass)	2 or 3 months	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
Change in gut microbiota alpha-diversity	2 months	Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics
Duration of intervention	Up to 3 months after study start	Duration of the study intervention, e.g. the willingness to continue FibreGum consumption for an additional month after 2 months of intervention

Trial Locations

Locations (1)

Department of Biomedical Research, University of Bern; 🇨🇭 Bern, Switzerland