Understanding how stress and diet affect obesity in adolescents
The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents (FAME)
This study is trying to see if tailored diet plans can help overweight teens aged 11 to 17 manage their weight better by looking at how stress and gut health affect them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 7 sites (Ghent, Oost-Vlaanderen and 6 other locations) |
| Trial ID | NCT06391671 on ClinicalTrials.gov |
What this trial studies
This project aims to develop personalized dietary interventions for adolescents aged 11 to 17 who are overweight or obese by examining the relationship between emotional stress, gut microbiome functionality, and dietary patterns. Participants will provide saliva, stool, and hair samples, along with completing questionnaires about their mental and medical health. The study will utilize metabolomics to analyze these samples and identify biomarkers associated with obesity and stress. The goal is to determine if personalized dietary approaches are more effective than general dietary recommendations.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 11 to 17 who are classified as overweight or obese.
Not a fit: Patients with type 1 diabetes, certain medical conditions, or those currently undergoing treatment with systemic corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored nutritional strategies that effectively address obesity in adolescents.
How similar studies have performed: While the approach of using metabolomics in this context is relatively novel, similar studies have shown promise in understanding the links between diet, stress, and obesity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 11-17 years Exclusion Criteria: * Obesity/overweight * Type 1 diabetes * Medical conditions including pancreatic failure * Developmental and hormonal disorders. E.g. thyroid problems, adrenal problems, Kallmann's syndrome, Klinefelter's syndrome, Prader-Willi syndrome (PWS), Congenital hypogonadotropic hypogonadism (CHH), ... * Pregnancy * In treatment with systemic concentrations of corticosteroids (cortisone). Eg cortisone/betamethasone/Dexamethasone/Fludrocortisone/Hydrocortisone in pill form or administration by injections.
Where this trial is running
Ghent, Oost-Vlaanderen and 6 other locations
- AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000 — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Clairs Vallons — Ottignies-Louvain-la-Neuve, Waals Brabant, Belgium (Recruiting)
- Zeepreventorium — De Haan, West-Vlaanderen, Belgium (Recruiting)
- AZ Delta — Roeselare, West-Vlaanderen, Belgium (Recruiting)
- UZ Antwerpen — Antwerp, Belgium (Recruiting)
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Stefaan de Henauw, Prof — University Hospital, Ghent
- Study coordinator: Emile Callemeyn, Dr
- Email: emile.callemeyn@ugent.be
- Phone: +32473271636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.