Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DCB Research AG | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Chewing gum containing maltitol powder |
|
| Interventional | Experimental | Chewing gums containing galactooligosaccharides (GOS) |
|
| No-treatment control | No Intervention | No chewing-gums |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Body Mass Index (BMI) during intervention | Difference in the BMI measured at intervention start and intervention completion | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressures change during intervention | Difference in systolic blood pressure (mm Hg) between intervention completion and intervention start. | 4 months |
| Diastolic blood pressures changes during intervention |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria L Balmer, Prof. med. | Contact | 031 632 26 19 | 0041 | maria.balmer@unibe.ch |
| Janina N Zünd, PhD | Contact | 031 632 26 19 | 0041 | janina.zuend@unibe.ch |
| Name | Affiliation | Role |
|---|---|---|
| Maria L Balmer, Prof. med. | Department of Biomedical Research, University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biomedical Research, University of Bern | Recruiting | Bern | 3010 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FibreGum | Dietary Supplement | To chew every day during a period of 4 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. |
|
Difference in diastolic blood pressure (mm Hg) between intervention completion and intervention start.
| 4 months |
| Self-reported weight changes during intervention | Difference in self-reported weight (kg) between intervention completion and intervention start. | 4 months |
| Self-reported weight changes during follow-up | Difference in self-reported weight (kg) between end of follow-up period and intervention completion. | 2 months from intervention completion (month 4) to end of follow-up period (month 6) |
| Waist circumference changes during intervention | Difference in waist circumference (cm) between between intervention completion and intervention start. | 4 months |
| Waist circumference changes during follow-up | Difference in waist circumference (cm) between end of follow-up period and intervention completion. | 2 months from intervention completion (month 4) to end of follow-up period (month 6) |
| Fasting blood glucose change during intervention | Difference in fasting blood glucose (mg/dL or mmol/L) between intervention completion and intervention start. | 4 months |
| Fasting insulin change during intervention | Difference in fasting insulin (mIU/mL) between intervention completion and intervention start. | 4 months |
| HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change during intervention | Difference in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between intervention completion and intervention start. Lower scores mean better outcome. | 4 months |
| Hemoglobin A1c (HbA1c) change during intervention | Difference in HbA1c (mmol/mol) between intervention completion and intervention start. | 4 months |
| Cholesterol change during intervention | Difference in Cholesterol (mg/dL) between intervention completion and intervention start. | 4 months |
| Triglyceride change during intervention | Difference in Triglyceride (mg/dL) between intervention completion and intervention start. | 4 months |
| High-density lipoproteins (HDL) change during intervention | Difference in HDL (mg/dL) between intervention completion and intervention start. | 4 months |
| Low-density lipoproteins (LDL) change during intervention | Difference in LDL (mg/dL) between intervention completion and intervention start. | 4 months |
| Neutrophils change during intervention | Difference in Neutrophils count (%) between intervention completion and intervention start. | 4 months |
| Lymphocytes change during intervention | Difference in Lymphocytes count (%) between intervention completion and intervention start. | 4 months |
| Monocyte change during intervention | Difference in Monocytes count (%) between intervention completion and intervention start. | 4 months |
| Eosinophils change during intervention | Difference in Eosinophils count (%) between intervention completion and intervention start. | 4 months |
| Basophils change during intervention | Difference in Basophils count (%) between intervention completion and intervention start. | 4 months |
| Alanine Aminotransferase (ALAT) change during intervention | Difference in ALAT (U/L) between intervention completion and intervention start. | 4 months |
| Aspartate Aminotransferase (ASAT) change during intervention | Difference in ASAT (U/L) between intervention completion and intervention start. | 4 months |
| Calcifediol (25OH-Vitamin D3) change during intervention | Difference in Calcifediol (nmol/L) between intervention completion and intervention start. | 4 months |
| Thyroid-Stimulating Hormone (TSH) change during intervention | Difference in TSH (mU/L) between intervention completion and intervention start. | 4 months |
| Ferritin change during intervention | Difference in Ferritin (μg/L) between intervention completion and intervention start. | 4 months |
| Proteinuria change during intervention | Difference in Proteinuria (g/24h) between intervention completion and intervention start. | 4 months |
| Oral microbiome change during intervention | Change in oral microbiota as assessed by metagenomic sequencing from oral washes between intervention completion and intervention start. | 4 months |
| Gut microbiome change during intervention | Change in intestinal microbiota-composition as assessed by metagenomic sequencing from stool samples between intervention completion and intervention start. | 4 months |
| Breath metabolome change during intervention | 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. | 4 months |
| Body composition change (body fat) during intervention | Change in body fat between intervention completion and intervention start. | 4 months |
| Body composition change (lean mass) during intervention | Change in lean mass between intervention completion and intervention start. | 4 months |
| Change in in-vitro response of faecal microbiota (alpha diversity) to a panel of prebiotic compounds during intervention | Change in community diversity (alpha diversity) assessed by metagenomic sequencing between intervention completion and intervention start. | 4 months |
| Change in in-vitro response of faecal microbiota (beta diversity) to a panel of prebiotic compounds during intervention | Change in composition (beta diversity, differential abundance) assessed by metagenomic sequencing between intervention completion and intervention start. | 4 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |