The FibreGum Study - Changing the Course of Obesity in Children

Adolescent Obesity Clinical Trial

— FibreGum  

Official title:

The FibreGum Study - Changing the Course of Obesity in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05540678
• Other study ID #: FibreGum
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Marie-Aline Gérard, Dr.
• Phone: +41782049811
• Email: marie-aline.gerard[@]dcberne.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Child Obesity
• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Obesity
• Pediatric Obesity

Intervention

Dietary Supplement:
• FibreGum
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
• Placebo
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.

Locations

Country	Name	City	State
Switzerland	Kinderklinik Bern	Berne

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	DCB Research AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fasting blood glucose change	Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.	6 months
Secondary	Fasting insulin change	Differences in fasting insulin (mIU/mL) between study completion and study start.	6 months
Secondary	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
Secondary	Hemoglobin A1c (HbA1c) change	Differences in HbA1c (mmol/mol) between study completion and study start.	6 months
Secondary	Lipid-profiles change	Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.	6 months
Secondary	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
Secondary	Differential blood count change	Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.	6 months
Secondary	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
Secondary	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
Secondary	Intestinal health	Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples	6 months
Secondary	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
Secondary	Alanine Aminotransferase (ALAT) change	Differences in ALAT between study completion and study start.	6 months
Secondary	Calcifediol (25OH-Vitamin D3) change	Differences in Calcifediol between study completion and study start.	6 months
Secondary	Thyroid-Stimulating Hormone (TSH) change	Differences in TSH between study completion and study start.	6 months
Secondary	Ferritin change	Differences in ferritin between study completion and study start.	6 months
Secondary	Proteinuria	Differences in proteinuria between study completion and study start.	6 months