Nutritional and Metabolic Diseases, Overweight
Conditions
Keywords
Overweight, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides), Oral microbiome, Intestinal microbiome
Brief 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.
Interventions
DIETARY_SUPPLEMENTPlacebo
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
DIETARY_SUPPLEMENTFibreGum
To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Sponsors
DCB Research AG
University of Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Body Mass Index (BMI) during intervention | 4 months | Difference in the BMI measured at intervention start and intervention completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressures change during intervention | 4 months | Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start. |
| Diastolic blood pressures changes during intervention | 4 months | Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start. |
| Self-reported weight changes during intervention | 4 months | Difference in self-reported weight (kg) between intervention completion and intervention start. |
| Self-reported weight changes during follow-up | 2 months from intervention completion (month 4) to end of follow-up period (month 6) | Difference in self-reported weight (kg) between end of follow-up period and intervention completion. |
| Waist circumference changes during intervention | 4 months | Difference in waist circumference (cm) between between intervention completion and intervention start. |
| Waist circumference changes during follow-up | 2 months from intervention completion (month 4) to end of follow-up period (month 6) | Difference in waist circumference (cm) between end of follow-up period and intervention completion. |
| Fasting blood glucose change during intervention | 4 months | Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start. |
| Fasting insulin change during intervention | 4 months | Difference in fasting insulin (mIU/mL) between intervention completion and intervention start. |
| HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention | 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 during intervention | 4 months | Difference in HbA1c (mmol/mol) between intervention completion and intervention start. |
| Cholesterol change during intervention | 4 months | Difference in Cholesterol (mg/dL) between intervention completion and intervention start. |
| Triglyceride change during intervention | 4 months | Difference in Triglyceride (mg/dL) between intervention completion and intervention start. |
| High-density lipoproteins (HDL) change during intervention | 4 months | Difference in HDL (mg/dL) between intervention completion and intervention start. |
| Low-density lipoproteins (LDL) change during intervention | 4 months | Difference in LDL (mg/dL) between intervention completion and intervention start. |
| Lymphocytes change during intervention | 4 months | Difference in Lymphocytes count (%) between intervention completion and intervention start. |
| Neutrophils change during intervention | 4 months | Difference in Neutrophils count (%) between intervention completion and intervention start. |
| Eosinophils change during intervention | 4 months | Difference in Eosinophils count (%) between intervention completion and intervention start. |
| Basophils change during intervention | 4 months | Difference in Basophils count (%) between intervention completion and intervention start. |
| Alanine Aminotransferase (ALAT) change during intervention | 4 months | Difference in ALAT (U/L) between intervention completion and intervention start. |
| Aspartate Aminotransferase (ASAT) change during intervention | 4 months | Difference in ASAT (U/L) between intervention completion and intervention start. |
| Calcifediol (25OH-Vitamin D3) change during intervention | 4 months | Difference in Calcifediol (nmol/L) between intervention completion and intervention start. |
| Thyroid-Stimulating Hormone (TSH) change during intervention | 4 months | Difference in TSH (mU/L) between intervention completion and intervention start. |
| Ferritin change during intervention | 4 months | Difference in Ferritin (μg/L) between intervention completion and intervention start. |
| Proteinuria change during intervention | 4 months | Difference in Proteinuria (g/24h) between intervention completion and intervention start. |
| Oral microbiome change during intervention | 4 months | Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start. |
| Gut microbiome change during intervention | 4 months | Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start. |
| Breath metabolome change during intervention | 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) during intervention | 4 months | Change in body fat between intervention completion and intervention start. |
| Body composition change (lean mass) during intervention | 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 during intervention | 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 during intervention | 4 months | Change in composition (beta diversity, differential abundance) assessed by metagenomic sequencing between intervention completion and intervention start. |
| Monocyte change during intervention | 4 months | Difference in Monocytes count (%) between intervention completion and intervention start. |
Countries
Switzerland
Contacts
Primary ContactMaria L Balmer, Prof. med.
Backup ContactJanina N Zünd, PhD
Outcome results
None listed