The FibreGum Study - Changing the Course of Obesity in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Chewing gum containing maltitol powder |
Dietary Supplement: Placebo
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
|
| Experimental: Investigational chewing gums containing fibers |
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.
|
| No Intervention: No-treatment control No study chewing gum |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- Lipid-profiles change [6 months]
Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) 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.
- 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.
- Intestinal health [6 months]
Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples
- 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.
Eligibility Criteria
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
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Obesity as determined by a BMI ≥97th percentile using the Swiss paediatric, age- and sex-matched growth charts
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Newly referred within the last month to a tertiary weight management clinic
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Participant willing to use the study specific monitoring app on his/her own or legal representatives' smartphone
Exclusion Criteria:
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Antibiotic administration in the last 6 months
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Pre- or probiotic treatment in the last 6 weeks
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Any professionally supervised treatment for weight management within the last year
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Consumption of more than one nicotine product per month (e.g. cigarette, gum)
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Adolescent females: any stages of known pregnancy or lactation period
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Congenital disorder affecting the cardiovascular, hepatic or respiratory system in a relevant way (as per PI's or specialist's evaluation)
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Malignant disease on treatment or previous tumour affecting the appetite system (e.g., suprasellar, hypothalamic tumours)
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Systemic antibiotic or anti-inflammatory medication (e.g. systemic intake of glucocorticoids) over the last 7 days
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Known eating disorder (medically diagnosed)
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Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
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Dependency from the sponsor or the clinical investigator
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Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, etc. of the participant and/or legal representative
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kinderklinik Bern | Berne | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- Diabetes Center Berne Research AG
Investigators
- Principal Investigator: Maria Luisa Balmer, Prof. med., Department of Biomedical Research, University Clinic of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FibreGum