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Competing study and lack of resource
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| Name | Class |
|---|---|
| DCB Research AG | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibreGum chewing gum | Dietary Supplement | Chewing gum containing galactooligosaccharides (GOS), delivering a total daily dose of 3 g of dietary fiber. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 3 months (end of chewing phase) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 3 months after study start |
| Reduction in body weight (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria L Balmer, Prof. med. | Department of Biomedical Research, University of Bern | Principal Investigator |
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| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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Mono-centre, single-arm, open-label feasibility study
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Reduction in percent of body weight between baseline and end of intervention
| 2 or 3 months |
| 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 | 2 or 3 months |
| 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 | 2 or 3 months |
| 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 | 2 or 3 months |
| Change in gut microbiota alpha-diversity | Change in microbial community diversity (alpha diversity) from baseline to timepoint 2, assessed by established diversity metrics | 2 months |
| Change in gut microbiota beta-diversity | Change in microbial community composition from baseline to timepoint 2, assessed by beta diversity metrics | 2 months |
| 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 | 2 months |
| Changes in body weight during follow-up | Changes in body weight from completion of intervention to end of study | 1 or 2 months |