The FibreGum Study - Changing the Course of Obesity in Children

Not Applicable

Recruiting

• Conditions: Nutritional and Metabolic Diseases; Child Obesity; Adolescent Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: FibreGum

• Registration Number: NCT05540678
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Study Start: 2022-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Chewing gum containing maltitol powder
Investigational	FibreGum	chewing gums containing fibers

Primary Outcome Measures

Name	Time	Method
Reduction in the Body Mass Index (BMI) Z-score	6 months	Difference in the BMI Z-scores measured at study start and study completion

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose change	6 months	Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.
Fasting insulin change	6 months	Differences in fasting insulin (mIU/mL) between study completion and study start.
Systolic and diastolic blood pressures changes	6 months	Differences in both systolic blood pressure and diastolic blood pressure (mm Hg) between study completion and study start.
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change	6 months	Differences in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between study completion and study start. Lower scores mean better outcome.
Hemoglobin A1c (HbA1c) change	6 months	Differences in HbA1c (mmol/mol) between study completion and study start.
Intestinal health	6 months	Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples
Alanine Aminotransferase (ALAT) change	6 months	Differences in ALAT between study completion and study start.
Thyroid-Stimulating Hormone (TSH) change	6 months	Differences in TSH between study completion and study start.
Ferritin change	6 months	Differences in ferritin between study completion and study start.
Proteinuria	6 months	Differences in proteinuria between study completion and study start.
Lipid-profiles change	6 months	Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.
Differential blood count change	6 months	Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.
Calprotectin and lipocalin-2 change in stool	6 months	Differences in calprotectin and lipocalin-2 (µg/g) in stool between study completion and study start as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Oral health	6 months	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.
Descriptive analysis of treatment adherence using data from an adherence-tracking app	6 months	The assessment of adherence to chewing-gum will be assessed as percentage (%) of chewing-gums chewed.
Calcifediol (25OH-Vitamin D3) change	6 months	Differences in Calcifediol between study completion and study start.

Trial Locations

Locations (2)

Kinderklinik Bern; 🇨🇭 Berne, Switzerland

Ostschweizer Kinderspital; 🇨🇭 St. Gallen, Switzerland