Adolescent Obesity Clinical Trial
— FibreGumOfficial title:
The FibreGum Study - Changing the Course of Obesity in Children
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Kinderklinik Bern | Berne |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | DCB Research AG |
Switzerland,
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 |
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