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Based on the Intention To Treat interim analysis results and the slow recruitment rate.
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| Name | Class |
|---|---|
| DCB Research AG | OTHER |
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The aim of this study is thus to assess the effect of a chewing gum containing fibres on body weight, metabolism and the oral and intestinal microbiomes in a population of obese children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Chewing gum containing maltitol powder |
|
| Investigational | Experimental | chewing gums containing fibers |
|
| No-treatment control | No Intervention | No study chewing gum |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibreGum | Dietary Supplement | To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the Body Mass Index (BMI) Z-score | Difference in the BMI Z-scores measured at study start and study completion | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose change | Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start. | 6 months |
| Fasting insulin change | Differences in fasting insulin (mIU/mL) between study completion and study start. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Luisa Balmer, Prof. med. | Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinderklinik Bern | Bern | 3010 | Switzerland | |||
| Ostschweizer Kinderspital |
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| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each. |
|
| 6 months |
| HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change | Differences in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between study completion and study start. Lower scores mean better outcome. | 6 months |
| Hemoglobin A1c (HbA1c) change | Differences in HbA1c (mmol/mol) between study completion and study start. | 6 months |
| Lipid-profiles change | Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start. | 6 months |
| Systolic and diastolic blood pressures changes | Differences in both systolic blood pressure and diastolic blood pressure (mm Hg) between study completion and study start. | 6 months |
| Differential blood count change | Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start. | 6 months |
| Calprotectin and lipocalin-2 change in stool | Differences in calprotectin and lipocalin-2 (µg/g) in stool between study completion and study start as determined by Enzyme-Linked Immunosorbent Assay (ELISA) | 6 months |
| Oral health | Changes in oral microbiota as assessed by 16S ribosomal ribonucleic acid (rRNA) gene sequencing from oral washes. Remark: The "S" in 16S is a sedimentation coefficient, that is, an index reflecting the downward velocity of the macromolecule in the centrifugal field. | 6 months |
| Intestinal health | Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples | 6 months |
| Descriptive analysis of treatment adherence using data from an adherence-tracking app | The assessment of adherence to chewing-gum will be assessed as percentage (%) of chewing-gums chewed. | 6 months |
| Alanine Aminotransferase (ALAT) change | Differences in ALAT between study completion and study start. | 6 months |
| Calcifediol (25OH-Vitamin D3) change | Differences in Calcifediol between study completion and study start. | 6 months |
| Thyroid-Stimulating Hormone (TSH) change | Differences in TSH between study completion and study start. | 6 months |
| Ferritin change | Differences in ferritin between study completion and study start. | 6 months |
| Proteinuria | Differences in proteinuria between study completion and study start. | 6 months |
| Sankt Gallen |
| 9000 |
| Switzerland |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |