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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
Kinderklinik Bern
Bern, Switzerland
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Reduction in the Body Mass Index (BMI) Z-score
Difference in the BMI Z-scores measured at study start and study completion
Time frame: 6 months
Fasting blood glucose change
Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.
Time frame: 6 months
Fasting insulin change
Differences in fasting insulin (mIU/mL) between study completion and study start.
Time frame: 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.
Time frame: 6 months
Hemoglobin A1c (HbA1c) change
Differences in HbA1c (mmol/mol) between study completion and study start.
Time frame: 6 months
Lipid-profiles change
Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.
Time frame: 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.
Time frame: 6 months
Differential blood count change
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Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.
Time frame: 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)
Time frame: 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.
Time frame: 6 months
Intestinal health
Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples
Time frame: 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.
Time frame: 6 months
Alanine Aminotransferase (ALAT) change
Differences in ALAT between study completion and study start.
Time frame: 6 months
Calcifediol (25OH-Vitamin D3) change
Differences in Calcifediol between study completion and study start.
Time frame: 6 months
Thyroid-Stimulating Hormone (TSH) change
Differences in TSH between study completion and study start.
Time frame: 6 months
Ferritin change
Differences in ferritin between study completion and study start.
Time frame: 6 months
Proteinuria
Differences in proteinuria between study completion and study start.
Time frame: 6 months