FaibaLite - Reduce Weight, One Bite at a Time

NCT07045766 | Withdrawn

• 1 other identifier: FaibaLite
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional and Metabolic Diseases

Keywords

Chewing gum; Galactooligosaccharides; GOS (Galactooligosaccharides); Intestinal microbiome; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of intervention

  Up to 3 months after study start

• Reduction in body weight (%)

  2 or 3 months

• Change in body composition (body fat)

  2 or 3 months

• Change in body composition (lean mass)

  2 or 3 months

• Change in body composition (muscle mass)

  2 or 3 months

Study Arms (1)

FibreGum Intervention Group

EXPERIMENTAL

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

Interventions

FibreGum chewing gum DIETARY_SUPPLEMENT

Chewing gum containing galactooligosaccharides (GOS), delivering a total daily dose of 3 g of dietary fiber.

FibreGum Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Officials

• Maria L Balmer, Prof. med.

  Department of Biomedical Research, University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mono-centre, single-arm, open-label feasibility study

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: January 1, 2026
• Primary Completion: February 28, 2026
• Study Completion: April 13, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)