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Nutritional and Metabolic DiseasesNCT07045766

FaibaLite - Reduce Weight, One Bite at a Time

A study testing FibreGum chewing gum in people with Nutritional and Metabolic Diseases, run by University of Bern.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nutritional and Metabolic Diseases
What is being tested?
FibreGum chewing gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 13 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

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.

Being tested
FibreGum chewing gum
Keywords
Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides), Intestinal microbiome, Gut microbiota
Medical subject headings
Nutritional and Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibreGum chewing gumDietary supplement

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

Study groups in NCT07045766
Study groupRoleWhat they receive
FibreGum Intervention GroupExperimentalParticipants 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.
Receives: Dietary Supplement: FibreGum chewing gum

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to 3 months (end of chewing phase)

Secondary outcomes (9)

  1. 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

    Measured: Up to 3 months after study start

  2. Reduction in body weight (%)

    Reduction in percent of body weight between baseline and end of intervention

    Measured: 2 or 3 months

  3. 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

    Measured: 2 or 3 months

  4. 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

    Measured: 2 or 3 months

  5. 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

    Measured: 2 or 3 months

  6. Change in gut microbiota alpha-diversity

    Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics

    Measured: 2 months

  7. Change in gut microbiota beta-diversity

    Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics

    Measured: 2 months

  8. 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

    Measured: 2 months

  9. Changes in body weight during follow-up

    Changes in body weight from completion of intervention to end of study

    Measured: 1 or 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start1 Jan 2026
  3. Primary completion28 Feb 2026
  4. Study completion13 Apr 2026

Why it stopped: Competing study and lack of resource

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Mono-centre, single-arm, open-label feasibility study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045766
Sponsor's protocol ID
FaibaLite
Status last verified
Apr 2026
First submitted
23 Jun 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FibreGum chewing gum in people with Nutritional and Metabolic Diseases, run by University of Bern.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate (time frame: Up to 3 months (end of chewing phase)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07045766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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