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The FibreGum Study - Changing the Course of Obesity in Children (FibreGum)

Primary Purpose

Nutritional and Metabolic Diseases, Child Obesity, Adolescent Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
FibreGum
Placebo
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional and Metabolic Diseases focused on measuring Obesity, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides)

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kinderklinik BernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

Placebo

Investigational

No-treatment control

Arm Description

Chewing gum containing maltitol powder

chewing gums containing fibers

No study chewing gum

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fasting blood glucose change
Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.
Fasting insulin change
Differences in fasting insulin (mIU/mL) between study completion and study start.
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.
Hemoglobin A1c (HbA1c) change
Differences in HbA1c (mmol/mol) between study completion and study start.
Lipid-profiles change
Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.
Systolic and diastolic blood pressures changes
Differences in both systolic blood pressure and diastolic blood pressure (mm Hg) between study completion and study start.
Differential blood count change
Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.
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)
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.
Intestinal health
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
The assessment of adherence to chewing-gum will be assessed as percentage (%) of chewing-gums chewed.
Alanine Aminotransferase (ALAT) change
Differences in ALAT between study completion and study start.
Calcifediol (25OH-Vitamin D3) change
Differences in Calcifediol between study completion and study start.
Thyroid-Stimulating Hormone (TSH) change
Differences in TSH between study completion and study start.
Ferritin change
Differences in ferritin between study completion and study start.
Proteinuria
Differences in proteinuria between study completion and study start.

Full Information

First Posted
September 5, 2022
Last Updated
July 12, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
DCB Research AG
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1. Study Identification

Unique Protocol Identification Number
NCT05540678
Brief Title
The FibreGum Study - Changing the Course of Obesity in Children
Acronym
FibreGum
Official Title
The FibreGum Study - Changing the Course of Obesity in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
DCB Research AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional and Metabolic Diseases, Child Obesity, Adolescent Obesity
Keywords
Obesity, Chewing gum, Galactooligosaccharides, GOS (Galactooligosaccharides)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Chewing gum containing maltitol powder
Arm Title
Investigational
Arm Type
Experimental
Arm Description
chewing gums containing fibers
Arm Title
No-treatment control
Arm Type
No Intervention
Arm Description
No study chewing gum
Intervention Type
Dietary Supplement
Intervention Name(s)
FibreGum
Intervention Description
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
To chew every day during a period of 6 months 3 chewing gums (morning, noon and evening) for at least 20 minutes each.
Primary Outcome Measure Information:
Title
Reduction in the Body Mass Index (BMI) Z-score
Description
Difference in the BMI Z-scores measured at study start and study completion
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fasting blood glucose change
Description
Differences in fasting blood glucose (mg/dL or mmol/L) between study completion and study start.
Time Frame
6 months
Title
Fasting insulin change
Description
Differences in fasting insulin (mIU/mL) between study completion and study start.
Time Frame
6 months
Title
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change
Description
Differences in Homeostatic Model Assessment of Insulin Resistance Index (min:0 - max:10) between study completion and study start. Lower scores mean better outcome.
Time Frame
6 months
Title
Hemoglobin A1c (HbA1c) change
Description
Differences in HbA1c (mmol/mol) between study completion and study start.
Time Frame
6 months
Title
Lipid-profiles change
Description
Differences in lipid-profiles (Cholesterol, Triglyceride, HDL, LDL in mg/dL) between study completion and study start.
Time Frame
6 months
Title
Systolic and diastolic blood pressures changes
Description
Differences in both systolic blood pressure and diastolic blood pressure (mm Hg) between study completion and study start.
Time Frame
6 months
Title
Differential blood count change
Description
Differences differential blood count (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils in %) between study completion and study start.
Time Frame
6 months
Title
Calprotectin and lipocalin-2 change in stool
Description
Differences in calprotectin and lipocalin-2 (µg/g) in stool between study completion and study start as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Time Frame
6 months
Title
Oral health
Description
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.
Time Frame
6 months
Title
Intestinal health
Description
Changes in intestinal microbiota-composition as assessed by metagenome sequencing from stool samples
Time Frame
6 months
Title
Descriptive analysis of treatment adherence using data from an adherence-tracking app
Description
The assessment of adherence to chewing-gum will be assessed as percentage (%) of chewing-gums chewed.
Time Frame
6 months
Title
Alanine Aminotransferase (ALAT) change
Description
Differences in ALAT between study completion and study start.
Time Frame
6 months
Title
Calcifediol (25OH-Vitamin D3) change
Description
Differences in Calcifediol between study completion and study start.
Time Frame
6 months
Title
Thyroid-Stimulating Hormone (TSH) change
Description
Differences in TSH between study completion and study start.
Time Frame
6 months
Title
Ferritin change
Description
Differences in ferritin between study completion and study start.
Time Frame
6 months
Title
Proteinuria
Description
Differences in proteinuria between study completion and study start.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Aline Gérard, Dr.
Phone
+41782049811
Email
marie-aline.gerard@dcberne.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luisa Balmer, Prof. med.
Organizational Affiliation
Department of Biomedical Research, University Clinic of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinderklinik Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Saner, Dr. med.
Phone
+41 31 632 14 52
Email
christoph.saner@insel.ch
First Name & Middle Initial & Last Name & Degree
Maria Luisa Balmer, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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The FibreGum Study - Changing the Course of Obesity in Children

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