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

Not Applicable
Not yet recruiting
Conditions
Nutritional and Metabolic Diseases
Overweight
Registration Number
NCT07036692
Lead Sponsor
University of Bern
Brief Summary

The main aim of this study is to assess the effect of a chewing gum containing galactooligosaccharides (GOS) on body weight (BMI reduction), metabolism and the oral and intestinal microbiomes in a population of overweight adults.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
120
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 and willing to use an electronic device (e.g., mobile phone, computer or tablet)

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)
  • Daily use of proton pump inhibitors (e.g., pantoprazole, omeprazole) during time of study
  • 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 insulin therapy
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Reduction in the Body Mass Index (BMI)4 months

Difference in the BMI measured at intervention start and intervention completion

Secondary Outcome Measures
NameTimeMethod
Systolic blood pressures change4 months

Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start.

Diastolic blood pressures changes4 months

Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.

Fasting blood glucose change4 months

Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start.

Fasting insulin change4 months

Difference in fasting insulin (mIU/mL) between intervention completion and intervention start.

HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change4 months

Difference in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between intervention completion and intervention start. Lower scores mean better outcome.

Hemoglobin A1c (HbA1c) change4 months

Difference in HbA1c (mmol/mol) between intervention completion and intervention start.

Cholesterol change4 months

Difference in Cholesterol (mg/dL) between intervention completion and intervention start.

Triglyceride change4 months

Difference in Triglyceride (mg/dL) between intervention completion and intervention start.

High-density lipoproteins (HDL) change4 months

Difference in HDL (mg/dL) between intervention completion and intervention start.

Low-density lipoproteins (LDL) change4 months

Difference in LDL (mg/dL) between intervention completion and intervention start.

Neutrophils change4 months

Difference in Neutrophils count (%) between intervention completion and intervention start.

Lymphocytes change4 months

Difference in Lymphocytes count (%) between intervention completion and intervention start.

Monocyte change4 months

Difference in Monocytes count (%) between intervention completion and intervention start.

Eosinophils change4 months

Difference in Eosinophils count (%) between intervention completion and intervention start.

Basophils change4 months

Difference in Basophils count (%) between intervention completion and intervention start.

Alanine Aminotransferase (ALAT) change4 months

Difference in ALAT (U/L) between intervention completion and intervention start.

Aspartate Aminotransferase (ASAT) change4 months

Difference in ASAT (U/L) between intervention completion and intervention start.

Calcifediol (25OH-Vitamin D3) change4 months

Difference in Calcifediol (nmol/L) between intervention completion and intervention start.

Thyroid-Stimulating Hormone (TSH) change4 months

Difference in TSH (mU/L) between intervention completion and intervention start.

Ferritin change4 months

Difference in Ferritin (μg/L) between intervention completion and intervention start.

Proteinuria change4 months

Difference in Proteinuria (g/24h) between intervention completion and intervention start.

Oral microbiome change4 months

Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start.

Gut microbiome change4 months

Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start.

Breath metabolome change4 months

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.

Body composition change (body fat)4 months

Change in body fat between intervention completion and intervention start.

Body composition change (lean mass)4 months

Change in lean mass between intervention completion and intervention start.

Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds4 months

Change in community diversity (alpha diversity) assessed by metagenomic sequencing between intervention completion and intervention start.

Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds4 months

Change in composition (beta diversity, differential abundance) assessed by metagenomic sequencing between intervention completion and intervention start.

Trial Locations

Locations (1)

Department of Biomedical Research, University of Bern

🇨🇭

Bern, Switzerland

Department of Biomedical Research, University of Bern
🇨🇭Bern, Switzerland
Maria L Balmer, Prof. med.
Contact
031 632 26 19
maria.balmer@unibe.ch
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