The FaibaGo Study - Long-Term Weight Reduction Via Low-Threshold Intervention
- Conditions
- Nutritional and Metabolic DiseasesOverweight
- 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
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Informed Consent (IC) according to ICH/GCP regulations prior to any study-specific procedures
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Adults aged ≥ 25 years
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Overweight as determined by a Body Mass Index > 25 kg/m2
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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
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Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing, faecal sample collection)
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Access and willing to use an electronic device (e.g., mobile phone, computer or tablet)
- 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
Name Time Method Reduction in the Body Mass Index (BMI) 4 months Difference in the BMI measured at intervention start and intervention completion
- Secondary Outcome Measures
Name Time Method Systolic blood pressures change 4 months Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start.
Diastolic blood pressures changes 4 months Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.
Fasting blood glucose change 4 months Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start.
Fasting insulin change 4 months Difference in fasting insulin (mIU/mL) between intervention completion and intervention start.
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change 4 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) change 4 months Difference in HbA1c (mmol/mol) between intervention completion and intervention start.
Cholesterol change 4 months Difference in Cholesterol (mg/dL) between intervention completion and intervention start.
Triglyceride change 4 months Difference in Triglyceride (mg/dL) between intervention completion and intervention start.
High-density lipoproteins (HDL) change 4 months Difference in HDL (mg/dL) between intervention completion and intervention start.
Low-density lipoproteins (LDL) change 4 months Difference in LDL (mg/dL) between intervention completion and intervention start.
Neutrophils change 4 months Difference in Neutrophils count (%) between intervention completion and intervention start.
Lymphocytes change 4 months Difference in Lymphocytes count (%) between intervention completion and intervention start.
Monocyte change 4 months Difference in Monocytes count (%) between intervention completion and intervention start.
Eosinophils change 4 months Difference in Eosinophils count (%) between intervention completion and intervention start.
Basophils change 4 months Difference in Basophils count (%) between intervention completion and intervention start.
Alanine Aminotransferase (ALAT) change 4 months Difference in ALAT (U/L) between intervention completion and intervention start.
Aspartate Aminotransferase (ASAT) change 4 months Difference in ASAT (U/L) between intervention completion and intervention start.
Calcifediol (25OH-Vitamin D3) change 4 months Difference in Calcifediol (nmol/L) between intervention completion and intervention start.
Thyroid-Stimulating Hormone (TSH) change 4 months Difference in TSH (mU/L) between intervention completion and intervention start.
Ferritin change 4 months Difference in Ferritin (μg/L) between intervention completion and intervention start.
Proteinuria change 4 months Difference in Proteinuria (g/24h) between intervention completion and intervention start.
Oral microbiome change 4 months Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start.
Gut microbiome change 4 months Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start.
Breath metabolome change 4 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 compounds 4 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 compounds 4 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, SwitzerlandMaria L Balmer, Prof. med.Contact031 632 26 19maria.balmer@unibe.ch