FaibaLite - Reduce Weight, One Bite at a Time

NCT ID: NCT07045766

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-03-31

Brief Summary

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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

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Conditions

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Nutritional and Metabolic Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mono-centre, single-arm, open-label feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FibreGum chewing gum

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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FibreGum chewing gum

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role lead

DCB Research AG

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria L Balmer, Prof. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Biomedical Research, University of Bern

Locations

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Department of Biomedical Research, University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Maria L Balmer, Prof. med.

Role: CONTACT

031 632 26 19 ext. 0041

Janina N Zünd, PhD

Role: CONTACT

031 632 26 19 ext. 0041

Facility Contacts

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Maria L Balmer, Prof. med.

Role: primary

031 632 26 19 ext. 0041

Other Identifiers

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FaibaLite

Identifier Type: -

Identifier Source: org_study_id

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