Nutritional and Metabolic Diseases
Conditions
Keywords
Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides), Intestinal microbiome, Gut microbiota
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.
Interventions
DIETARY_SUPPLEMENTFibreGum chewing gum
Chewing gum containing galactooligosaccharides (GOS), delivering a total daily dose of 3 g of dietary fiber.
Sponsors
University of Bern
DCB Research AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mono-centre, single-arm, open-label feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Reduction in body weight (%) | 2 or 3 months | Reduction in percent of body weight between baseline and end of intervention |
| 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 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 gut microbiota alpha-diversity | 2 months | Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics |
| Change in gut microbiota beta-diversity | 2 months | Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics |
| 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 |
| Changes in body weight during follow-up | 1 or 2 months | Changes in body weight from completion of intervention to end of study |
Contacts
PRINCIPAL_INVESTIGATORMaria L Balmer, Prof. med.
Department of Biomedical Research, University of Bern
Outcome results
None listed