Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05540678
Other study ID # FibreGum
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Not yet recruiting NCT04310371 - Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX) N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Completed NCT03364205 - Solution Focused Approach in Adolescents (SFA) N/A
Recruiting NCT04837586 - Self-Weighing for Adolescents Seeking Obesity Treatment N/A
Completed NCT05329753 - Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents N/A
Active, not recruiting NCT03843424 - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers N/A
Completed NCT03516097 - TeenPower: e-Empowering Teenagers to Prevent Obesity N/A
Active, not recruiting NCT04522921 - Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns N/A
Active, not recruiting NCT03584217 - Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study Phase 1/Phase 2
Active, not recruiting NCT03620773 - Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes Phase 1/Phase 2
Recruiting NCT03263351 - Depression & Insulin Sensitivity in Adolescents N/A
Completed NCT03458637 - Lifestyle Intervention of Obese Teenagers (LITE) Program N/A
Active, not recruiting NCT04007393 - SMART Use of Medication for the Treatment of Adolescent Severe Obesity Phase 2
Active, not recruiting NCT03587727 - Hepatic Mitochondrial Function in Youth
Not yet recruiting NCT04112251 - Effects of COcoa Supplement in OBese Adolescent Subjects N/A
Recruiting NCT05623007 - Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection N/A
Completed NCT03516721 - Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology N/A
Active, not recruiting NCT03919929 - Treating PCOS With Semaglutide vs Active Lifestyle Intervention Phase 2/Phase 3