NCT06391671Recruiting
The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents
The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents (FAME)
Source: ClinicalTrials.gov · Last updated 30 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 11 Jan 2022
- Primary completion date
- Jul 2027
- Lead sponsor
- University Ghent
- Diseases
- Obesity
- NCT number
- NCT06391671
What you commit to
- Study type: Observational
- Planned participants: 750
- From 11 Jan 2022 to the primary completion date, Jul 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In treatment with systemic concentrations of corticosteroids (cortisone). Eg cortisone/betamethasone/Dexamethasone/Fludrocortisone/Hydrocortisone in pill form or administration by injections.
Other illness
- 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), ...
Other
- Obesity/overweight
- Pregnancy
Who the study is looking for
- Age 11-17 years
Age in the registry: 11 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ZNA Middelheim Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| UZ Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Zeepreventorium Coordinator of this site? Confirm its status | De Haan | Belgium | Recruiting |
| AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000 Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Ghent university hospital Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Clairs Vallons Coordinator of this site? Confirm its status | Ottignies-Louvain-la-Neuve | Belgium | Recruiting |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.