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

Recruiting · NCT06391671 · Observational (researchers observe without assigning treatment)

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Interventions studied

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

What this trial is about

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.

Who can take part

Age range

11 Years to 17 Years

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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 it is running

7 locations listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →