Clinical Trial

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

Study acronym: FAME
Recruiting
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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.
Trial Details
NCT Number NCT06391671
Lead Sponsor University Ghent
Conditions Pediatric Obesity
Enrollment 750 participants
Start Date 2022-01-11
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2024-04-30