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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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ZNA Middelheim
Coordinator of this site? Confirm its status
AntwerpBelgiumRecruiting
UZ Antwerpen
Coordinator of this site? Confirm its status
AntwerpBelgiumRecruiting
Zeepreventorium
Coordinator of this site? Confirm its status
De HaanBelgiumRecruiting
AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Ghent university hospital
Coordinator of this site? Confirm its status
GhentBelgiumRecruiting
Clairs Vallons
Coordinator of this site? Confirm its status
Ottignies-Louvain-la-NeuveBelgiumRecruiting
AZ Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.