The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
NCT ID: NCT07036692
Last Updated: 2025-11-21
Study Results
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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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-10-09
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Chewing gum containing maltitol powder
Placebo
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Interventional
Chewing gums containing galactooligosaccharides (GOS)
FibreGum
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
No-treatment control
No chewing-gums
No interventions assigned to this group
Interventions
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Placebo
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
FibreGum
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Eligibility Criteria
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Inclusion Criteria
* 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:
i. 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)
* 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.
Exclusion Criteria
* 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)
* 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
25 Years
ALL
No
Sponsors
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University of Bern
OTHER
DCB Research AG
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FaibaGo
Identifier Type: -
Identifier Source: org_study_id
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