The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents
NCT ID: NCT06391671
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2022-01-11
2027-07-31
Brief Summary
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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.
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Detailed Description
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In WP2 the investigators will assess the microbiome and diet as drivers for obesity. Fecal samples will be subjected to DNA extraction and whole-metagenome shotgun sequencing will be performed using the Illumina HiSeq 2500 system (151 bp paired-end reads; Novogene). In order to collect data about both long- and short-term dietary intakes, participants will be provided with a FFQ and a 24-h recall.
Eventually, discovery of metabolite marker signatures and elucidation of mechanistic pathways will offer opportunities to stratify obese adolescents according to emotional stress status, microbial composition and dietary preferences.
In WP3, the new data from WP1/2 will be translated in personalized dietary recommendations. The investigators will assess the potential of dietary interventions focused on nutrient quality (not energy-reduced) to affect the stress-obesity axis directly or by gut microbial modulation. After ethical approval, the dietary intervention study will include up to 20 individuals that were allocated to the overweight/obesity group. In our 3-month personalized intervention, separate menus for each participant will be prepared by our dietician. Based on WP1/2 and literature evidence, appropriate changes in nutrients will be aimed for. At different points in time, fecal samples will be collected, aliquoted and biobanked at -80°C. Fecal samples will be used for polar metabolomics and lipidomics analyses and microbiome metasequencing. At the start and after the 3-months intervention, fasting blood samples will be taken for clinical biomarkers (glucose, insulin, cholesterol, cytokines, ...). In addition, indirect calorimetry will determine resting energy expenditure. Anthropometric measures include BMI, waist and fat%. Questionnaires cover emotional eating (DEBQ), satiety, physical activity, sleep and quality-of-life (KINDL). Study volunteers will be asked to fill out an FFQ and 3-day 24-h recall to assess dietary habits prior to the trial.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Overweight/obese
BMI-Z \> 25
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.)
Normal weight
BMI-Z \< 25
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.)
Interventions
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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.)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
11 Years
17 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Stefaan de Henauw, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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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
UZ Antwerpen
Antwerp, , Belgium
ZNA Middelheim
Antwerp, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BC-10583
Identifier Type: -
Identifier Source: org_study_id
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