NCT05540678

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

September 5, 2022

Last Update Submit

February 16, 2026

Conditions

Nutritional and Metabolic DiseasesChild ObesityAdolescent Obesity

Keywords

ObesityChewing gumGalactooligosaccharidesGOS (Galactooligosaccharides)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Fasting blood glucose change

    6 months

  • Fasting insulin change

    6 months

  • HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR) index change

    6 months

  • Hemoglobin A1c (HbA1c) change

    6 months

  • Lipid-profiles change

    6 months

  • +11 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Chewing gum containing maltitol powder

Dietary Supplement: Placebo

Investigational

EXPERIMENTAL

chewing gums containing fibers

Dietary Supplement: FibreGum

No-treatment control

NO INTERVENTION

No study chewing gum

Interventions

FibreGumDIETARY_SUPPLEMENT

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

Investigational
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kinderklinik Bern

Bern, 3010, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, 9000, Switzerland

Location

MeSH Terms

Conditions

Nutritional and Metabolic DiseasesPediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Luisa Balmer, Prof. med.

    Department of Biomedical Research, Children Clinic Berne, Inselspital, Bern University Hospital University of Bern

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 15, 2022

Study Start

November 30, 2022

Primary Completion

January 23, 2026

Study Completion

January 23, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)