The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents
FAME
1 other identifier
observational
750
1 country
7
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2022
CompletedFirst Submitted
Initial submission to the registry
April 19, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
April 30, 2024
April 1, 2024
5.5 years
April 19, 2024
April 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolomics
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.
Samples will be analyzed in the 4th quarter of 2024.
Secondary Outcomes (3)
Microbiome analysis
Microbiome analyses will be performed at the start of 2025
Stress levels
Hair cortisol analyses will be conducted in the first quarter of 2025. Data processing of the questionnaires is an ongoing process, to be completed by the last quarter of 2024
Food frequency questionnaire
FFQ data are being analyzed continuously and will be finished when the sample collection is finished (estimated by the end of 2024)
Study Arms (2)
Overweight/obese
BMI-Z \> 25
Normal weight
BMI-Z \< 25
Interventions
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.)
Eligibility Criteria
Volunteers with normall weight and overweight/obesity are being recruited from several hospitals (UZ Ghent, AZ Jan Palfijn, UZ Antwerpen, ZNA Middelheim, AZ Delta Roeselare, UZ Brussel, UZ Leuven, Onze-Lieve-Vrouw Ziekenhuis Aalst, AZ Sint-Lucas Brugge, AZ Sint-Elizabeth Zottegem, Zeepreventorium, Clairs Vallons) and schools (Don-Bosco Sint-Denijs-Westrem, Leiepoort Deinze, Broederschool Sint-Niklaas, SFI Melle) in Belgium
You may qualify if:
- Age 11-17 years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Study Sites (7)
AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000
Ghent, Oost-Vlaanderen, 9000, Belgium
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000, Belgium
Clairs Vallons
Ottignies-Louvain-la-Neuve, Waals Brabant, 1340, Belgium
Zeepreventorium
De Haan, West-Vlaanderen, 8420, Belgium
AZ Delta
Roeselare, West-Vlaanderen, 8800, Belgium
UZ Antwerpen
Antwerp, 2000, Belgium
ZNA Middelheim
Antwerp, 2000, Belgium
Biospecimen
Stool, saliva and hair
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefaan de Henauw, Prof
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2024
First Posted
April 30, 2024
Study Start
January 11, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared with other researchers