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Recruiting NCT07036692

The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention

No phase Interventional Nutritional and Metabolic Diseases Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, FibreGum.
Who it may be relevant to
Registry conditions: Nutritional and Metabolic Diseases, Overweight. Basic parameters: from 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Dietary supplement Placebo
    To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
  • Dietary supplement FibreGum
    To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

Primary outcome measures

  • Change in the Body Mass Index (BMI) during intervention [Time frame: 4 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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:

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

  • 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Department of Biomedical Research, University of Bern — Bern

Identifiers

NCT: NCT07036692 · FaibaGo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗