Nutritional and Metabolic DiseasesNCT07036692
The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
A study testing FibreGum in people with Nutritional and Metabolic Diseases and Overweight, run by University of Bern at 1 site in Switzerland.
Trial summary
The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on the body mass index (BMI), the metabolism and the oral and intestinal microbiomes in a population of overweight adults. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Nutritional and Metabolic Diseases, Overweight
- What is being tested?
- FibreGum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures
- Adults aged ≥ 25 years
- Overweight as determined by a Body Mass Index > 25 kg/m2
- Metabolic risk factor: at least one of the following criteria:
- HbA1c ≥ 5.7% ii. Elevated liver enzymes (ALAT, ASAT, Gamma-Glutamyltransferase (gGT) at least one above normal range of the assay used in the respective laboratory) iii. LDL-cholesterol > 3.0 mmol/l iv. Triglycerides > 1.7 mmol/l
- Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
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- Access to a scale to self-report weight
- Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)
- Laboratory assessments of blood parameters were performed within a reasonable timeframe prior to the eligibility assessment, as determined by the PI.
Who cannot join
- Systemic antibiotic use within the last 2 months
- History of bariatric surgery
- Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)
- Use of prebiotic or probiotic supplementation (duration >1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)
- Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)
- Recent (<1 month) dose adjustment, initiation or termination of proton pump inhibitors use (e.g., pantoprazole, omeprazole)
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- Professionally supervised intensive (>6 months of ongoing supervision) weight management treatments (e.g., structured nutrition counselling) within the last year (at the PI's discretion)
- Diagnosis of Type 1 or Type 2 diabetes requiring bolus insulin therapy or frequent dose adjustments in base line insulin
- Regular alcohol consumption exceeding two (women) or three (men) standard units (10 g of pure alcohol) per day
- Consumption of more than one nicotine product (e.g., (e-)cigarette, gum) per month
- Regular drug abuse (once per week over the past 4 months)
- Any stage of known pregnancy or lactation period (self-reported)
- Active cancer or recent cancer treatment (within the last 4 months)
- Chronic, active inflammatory diseases (e.g., inflammatory bowel disease, rheumatoid arthritis)
- Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, gastroparesis)
- Known eating disorder (medically diagnosed)
- Participation in another investigation with an investigational drug within the 30 days preceding randomisation
- Dependency from the Sponsor-Investigator
- Last visit with TP > 22 days prior to eligibility assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Biomedical Research, University of Bern
Bern, 3010
Maria L Balmer, Prof. med., 031 632 26 19 ext. 0041, maria.balmer@unibe.ch
About this study
The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on the body mass index (BMI), the metabolism and the oral and intestinal microbiomes in a population of overweight adults.
- Conditions
- Nutritional and Metabolic Diseases, Overweight
- Being tested
- Placebo, FibreGum
- Keywords
- Overweight, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides), Oral microbiome, Intestinal microbiome
- Medical subject headings
- Nutritional and Metabolic Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
FibreGumDietary supplement
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Chewing gum containing maltitol powder Receives: Dietary Supplement: Placebo |
| Interventional | Experimental | Chewing gums containing galactooligosaccharides (GOS) Receives: Dietary Supplement: FibreGum |
| No-treatment control | No intervention | No chewing-gums |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Body Mass Index (BMI) during intervention
Difference in the BMI measured at intervention start and intervention completion
Measured: 4 months
Secondary outcomes (32)
Systolic blood pressures change during intervention
Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start.
Measured: 4 months
Diastolic blood pressures changes during intervention
Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.
Measured: 4 months
Self-reported weight changes during intervention
Difference in self-reported weight (kg) between intervention completion and intervention start.
Measured: 4 months
Self-reported weight changes during follow-up
Difference in self-reported weight (kg) between end of follow-up period and intervention completion.
Measured: 2 months from intervention completion (month 4) to end of follow-up period (month 6)
Waist circumference changes during intervention
Difference in waist circumference (cm) between between intervention completion and intervention start.
Measured: 4 months
Waist circumference changes during follow-up
Difference in waist circumference (cm) between end of follow-up period and intervention completion.
Measured: 2 months from intervention completion (month 4) to end of follow-up period (month 6)
Fasting blood glucose change during intervention
Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start.
Measured: 4 months
Fasting insulin change during intervention
Difference in fasting insulin (mIU/mL) between intervention completion and intervention start.
Measured: 4 months
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention
Difference in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between intervention completion and intervention start. Lower scores mean better outcome.
Measured: 4 months
Hemoglobin A1c (HbA1c) change during intervention
Difference in HbA1c (mmol/mol) between intervention completion and intervention start.
Measured: 4 months
Cholesterol change during intervention
Difference in Cholesterol (mg/dL) between intervention completion and intervention start.
Measured: 4 months
Triglyceride change during intervention
Difference in Triglyceride (mg/dL) between intervention completion and intervention start.
Measured: 4 months
High-density lipoproteins (HDL) change during intervention
Difference in HDL (mg/dL) between intervention completion and intervention start.
Measured: 4 months
Low-density lipoproteins (LDL) change during intervention
Difference in LDL (mg/dL) between intervention completion and intervention start.
Measured: 4 months
Neutrophils change during intervention
Difference in Neutrophils count (%) between intervention completion and intervention start.
Measured: 4 months
Lymphocytes change during intervention
Difference in Lymphocytes count (%) between intervention completion and intervention start.
Measured: 4 months
Monocyte change during intervention
Difference in Monocytes count (%) between intervention completion and intervention start.
Measured: 4 months
Eosinophils change during intervention
Difference in Eosinophils count (%) between intervention completion and intervention start.
Measured: 4 months
Basophils change during intervention
Difference in Basophils count (%) between intervention completion and intervention start.
Measured: 4 months
Alanine Aminotransferase (ALAT) change during intervention
Difference in ALAT (U/L) between intervention completion and intervention start.
Measured: 4 months
Aspartate Aminotransferase (ASAT) change during intervention
Difference in ASAT (U/L) between intervention completion and intervention start.
Measured: 4 months
Calcifediol (25OH-Vitamin D3) change during intervention
Difference in Calcifediol (nmol/L) between intervention completion and intervention start.
Measured: 4 months
Thyroid-Stimulating Hormone (TSH) change during intervention
Difference in TSH (mU/L) between intervention completion and intervention start.
Measured: 4 months
Ferritin change during intervention
Difference in Ferritin (μg/L) between intervention completion and intervention start.
Measured: 4 months
Proteinuria change during intervention
Difference in Proteinuria (g/24h) between intervention completion and intervention start.
Measured: 4 months
Oral microbiome change during intervention
Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start.
Measured: 4 months
Gut microbiome change during intervention
Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start.
Measured: 4 months
Breath metabolome change during intervention
Change in volatile compounds present in the breath detected by secondary electrospray ionization (SESI) source in combination with a high-resolution mass spectrometry (HR-MS) between intervention completion and intervention start.
Measured: 4 months
Body composition change (body fat) during intervention
Change in body fat between intervention completion and intervention start.
Measured: 4 months
Body composition change (lean mass) during intervention
Change in lean mass between intervention completion and intervention start.
Measured: 4 months
Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds during intervention
Change in community diversity (alpha diversity) assessed by metagenomic sequencing between intervention completion and intervention start.
Measured: 4 months
Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds during intervention
Change in composition (beta diversity, differential abundance) assessed by metagenomic sequencing between intervention completion and intervention start.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start9 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- DCB Research AG
- Responsible party
- Sponsor
- Investigators
- Maria L Balmer, Prof. med., Principal investigator, Department of Biomedical Research, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036692
- Sponsor's protocol ID
- FaibaGo
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
- ClinicalTrials.gov ID
- NCT07036692
- Acronym / sponsor ID
- FaibaGo
- Conditions
- Nutritional and Metabolic Diseases, Overweight
- Keywords
- Overweight, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides), Oral microbiome, Intestinal microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- DCB Research AG
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on the body mass index (BMI), the metabolism and the oral and intestinal microbiomes in a population of overweight adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboChewing gum containing maltitol powder |
| Interventional | Experimental | Dietary Supplement: FibreGumChewing gums containing galactooligosaccharides (GOS) |
| No-treatment control | No intervention | –No chewing-gums |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures
- Adults aged ≥ 25 years
- Overweight as determined by a Body Mass Index > 25 kg/m2
- Metabolic risk factor: at least one of the following criteria:
- Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
Key exclusion criteria (19 listed)
- Systemic antibiotic use within the last 2 months
- History of bariatric surgery
- Initiation or dose adjustment of pharmaceutical treatment for dyslipidemia or hyperglycemia within the last 3 months or during the study (e.g., metformin, statins, SGLT2 inhibitors)
- Use of prebiotic or probiotic supplementation (duration >1 month) within the last 6 weeks (at PI's discretion, based on medication summary of TP)
- Medical weight management treatments within the last year (e.g., Glucagon-Like Peptide-1 (GLP-1) agonists)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTo chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. | Dietary supplement | Placebo |
| FibreGumTo chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. | Dietary supplement | Interventional |
Primary outcome
Change in the Body Mass Index (BMI) during intervention
Time frame: 4 months
Difference in the BMI measured at intervention start and intervention completion
32 secondary outcomes
Systolic blood pressures change during intervention
Time frame: 4 months
Diastolic blood pressures changes during intervention
Time frame: 4 months
Self-reported weight changes during intervention
Time frame: 4 months
Self-reported weight changes during follow-up
Time frame: 2 months from intervention completion (month 4) to end of follow-up period (month 6)
Waist circumference changes during intervention
Time frame: 4 months
Waist circumference changes during follow-up
Time frame: 2 months from intervention completion (month 4) to end of follow-up period (month 6)
Fasting blood glucose change during intervention
Time frame: 4 months
Fasting insulin change during intervention
Time frame: 4 months
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention
Time frame: 4 months
Hemoglobin A1c (HbA1c) change during intervention
Time frame: 4 months
Cholesterol change during intervention
Time frame: 4 months
Triglyceride change during intervention
Time frame: 4 months
High-density lipoproteins (HDL) change during intervention
Time frame: 4 months
Low-density lipoproteins (LDL) change during intervention
Time frame: 4 months
Neutrophils change during intervention
Time frame: 4 months
Lymphocytes change during intervention
Time frame: 4 months
Monocyte change during intervention
Time frame: 4 months
Eosinophils change during intervention
Time frame: 4 months
Basophils change during intervention
Time frame: 4 months
Alanine Aminotransferase (ALAT) change during intervention
Time frame: 4 months
Aspartate Aminotransferase (ASAT) change during intervention
Time frame: 4 months
Calcifediol (25OH-Vitamin D3) change during intervention
Time frame: 4 months
Thyroid-Stimulating Hormone (TSH) change during intervention
Time frame: 4 months
Ferritin change during intervention
Time frame: 4 months
Proteinuria change during intervention
Time frame: 4 months
Oral microbiome change during intervention
Time frame: 4 months
Gut microbiome change during intervention
Time frame: 4 months
Breath metabolome change during intervention
Time frame: 4 months
Body composition change (body fat) during intervention
Time frame: 4 months
Body composition change (lean mass) during intervention
Time frame: 4 months
Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds during intervention
Time frame: 4 months
Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds during intervention
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria L Balmer, Prof. med. principal investigator
Department of Biomedical Research, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibreGum in people with Nutritional and Metabolic Diseases and Overweight, run by University of Bern at 1 site in Switzerland.
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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria L Balmer, Prof. med. (031 632 26 19 ext. 0041, maria.balmer@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Body Mass Index (BMI) during intervention (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.