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Recruiting Observational

The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents

NCT06391671 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2022-01-11
Last updated
2024-04-30

Condition(s) studied

Pediatric Obesity

Investigational drug(s) / intervention(s)

Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data)

Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data): Saliva and feces are collected at the families home. A questionnaire is filled in by the participant (psychological) and parents (demographical and medical info). Upon consultation we are collecting anthropometric data (date of birth, length, weight, abdominal circumference, Tanner pubertal stage, etc.)

Study 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

Sex
ALL
Min age
11 Years
Max age
17 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Metabolomics — Samples will be analyzed in the 4th quarter of 2024.
    Saliva and fecal samples will be analyzed using a technique called metabolomics, which analyses all small molecules (metabolites) present in a biological fluid. These metabolites will be used to find biomarkers that are related to the disease and could have diagnostic or prognostic potential. Additionally, these metabolites could give more insights into the development and maintenance of the disease.

Trial sites (7)

FacilityCityRegionStatus
AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000 Ghent Oost-Vlaanderen Recruiting
Ghent University Hospital Ghent Oost-Vlaanderen Recruiting
Clairs Vallons Ottignies-Louvain-la-Neuve Waals Brabant Recruiting
Zeepreventorium De Haan West-Vlaanderen Recruiting
AZ Delta Roeselare West-Vlaanderen Recruiting
UZ Antwerpen Antwerp Belgium Recruiting
ZNA Middelheim Antwerp Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06391671 on ClinicalTrials.gov ↗ ← All trials in Belgium