The FibreGum Study - Changing the Course of Obesity in Children

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The FibreGum Study - Changing the Course of Obesity in Children

Conditions
-----------------
Nutritional and Metabolic Diseases, Child Obesity, Adolescent Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: FibreGum
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP) regulations prior to any study specific procedures Obesity as determined by a BMI ≥97th percentile using the Swiss paediatric, age- and sex-matched growth charts Newly referred within the last month to a tertiary weight management clinic Participant willing to use the study specific monitoring app on his/her own or legal representatives' smartphone Exclusion Criteria: Antibiotic administration in the last 6 months Pre- or probiotic treatment in the last 6 weeks Any professionally supervised treatment for weight management within the last year Consumption of more than one nicotine product per month (e.g. cigarette, gum) Adolescent females: any stages of known pregnancy or lactation period Congenital disorder affecting the cardiovascular, hepatic or respiratory system in a relevant way (as per PI's or specialist's evaluation) Malignant disease on treatment or previous tumour affecting the appetite system (e.g., suprasellar, hypothalamic tumours) Systemic antibiotic or anti-inflammatory medication (e.g. systemic intake of glucocorticoids) over the last 7 days Known eating disorder (medically diagnosed) Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation Dependency from the sponsor or the clinical investigator Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, etc. of the participant and/or legal representative

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Chewing gum containing maltitol powder | Dietary Supplement: Placebo<br>* To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.<br>|
| Experimental: Investigational<br>chewing gums containing fibers | Dietary Supplement: FibreGum<br>* To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.<br>|
| No Intervention: No-treatment control<br>No study chewing gum | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides)