NCT06391671 The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents
| NCT ID | NCT06391671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Pediatric Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2022-01-11 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2022-01-11 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The ultimate aim of this project is to establish a validated strategy that allows for personalized intervention in adolescents (11 to 17 years) whom are assigned a state of overweight or obesity. The investigators will assess the following hypotheses: * Weight condition is reflected by the fecal metabolome (WP1) * Emotional stress is implicated in weight condition (WP1) * Functionality of the gut microbiome is related to the diet-stress-obesity axis (WP2) * Dietary pattern impacts the fecal metabolome and gut microbiome (WP2) * Personalized dietary intervention outperforms generalized dietary approaches (WP3) Participants will: * Produce a saliva, stool and hair sample * Fill in questionnaires regarding mental health, medical health and demographic information * Fill in a food frequency questionnaire and a 24-hrecalls * Be measured (height, weight, fat% and waist circumference) The samples will be analyzed using a technique called metabolomics to identify biomarker candidates with diagnostic and/or prognostic potential. Additionally, microbiome analysis will be performed to map the microbiome of all groups.
Eligibility 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.
Contact & Investigator
Stefaan de Henauw, Prof
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06391671 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Pediatric Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06391671 currently recruiting?
Yes, NCT06391671 is actively recruiting participants. Contact the research team at emile.callemeyn@ugent.be for enrollment information.
Where is the NCT06391671 trial being conducted?
This trial is being conducted at Ghent, Belgium, Ghent, Belgium, Ottignies-Louvain-la-Neuve, Belgium, De Haan, Belgium and 3 additional locations.
Who is sponsoring the NCT06391671 clinical trial?
NCT06391671 is sponsored by University Ghent. The principal investigator is Stefaan de Henauw, Prof at University Hospital, Ghent. The trial plans to enroll 750 participants.
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