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Pediatric ObesityFAMENCT06391671

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

An observational study of Pediatric Obesity, run by University Ghent at 7 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
What is being tested?
Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data)
How many people
750 participants
Where
7 sitesBelgium
Study dates
11 Jan 2022to Jul 2027
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 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

Who may be able to join

  • Age 11-17 years

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emile Callemeyn, Dr contact

+32473271636

emile.callemeyn@ugent.be

Lynn Vanhaecke, Prof contact

0032 9 264 74 57

Lynn.Vanhaecke@ugent.be

7 sites in 1 country

Belgium7 sites, 7 recruiting
  • UZ Antwerpen

    Antwerp, 2000

    Karolien Van de Maele, Prof, +32 3 821 32 51, karolien.vandemaele@uza.be

    Recruiting
  • ZNA Middelheim

    Antwerp, 2000

    Daniel Klink, Dr, daniel.klink@zna.be

    Recruiting
  • Zeepreventorium

    De Haan, West-Vlaanderen, 8420

    Ann Tanghe, Ann.tanghe@zeepreventorium.be

    Recruiting
  • AZ Jan Palfijn Gent, Oost-Vlaanderen, Belgium, 9000

    Ghent, Oost-Vlaanderen, 9000

    Nele Baeck, Dr, Nele.Baeck@janpalfijngent.be

    Recruiting
  • Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

    Stefaan de Henauw, Prof, +32 9 332 36 79, Stefaan.deHenauw@UGent.be

    Recruiting
  • Clairs Vallons

    Ottignies-Louvain-la-Neuve, Waals Brabant, 1340

    Laure Joachim, Dr, laurejoachim@clairsvallons.be

    Recruiting
  • AZ Delta

    Roeselare, West-Vlaanderen, 8800

    Els Ide, dr, els.ide@azdelta.be

    Recruiting

Other trials in Belgium

About this study

Official title: The Stress-obesity Axis: a Metabolomics Approach Towards Personalized Nutrition in Adolescents (FAME)

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:

Read more
  • 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.

Read the detailed description

In WP1, the investigators will assess the metabolic mechanisms underlying the obesity pathology in adolescents, whereby the involvement of emotional stress, will be of particular interest. To this end, a dual strategy fecal metabolomics will be performed: targeted profiling and untargeted fingerprinting. A major objective in this respect is to metabolically segregate between the overweight/obesity and normal weight condition as well as to reveal metabolic singularities that specifically relate to emotional stress. Fecal material, saliva and a hair sample will be collected from adolescents (11 to 17 years). Assignment of a participant's stress state will be performed post-hoc and based on hair cortisol concentrations and scores from the psychological questionnaires. The samples will be collected at home and have to be frozen immediately after sample collection. The samples will be analyzed using a technique called metabolomics, using UHPLC-HRMS (Ultra-High Performance Liquid Chromatography coupled to High-Resolution Mass Spectrometry).

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.

Being tested
Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data)
Keywords
Metabolomic, Mass spectrometry
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.)

Study groups in NCT06391671
Study groupRoleWhat they receive
Overweight/obeseBMI-Z > 25
Receives: Other: Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data)
Normal weightBMI-Z < 25
Receives: Other: Collection of anthropometric data, biological samples (stool, saliva and hair), questionnaires (demographic data, psychological data, medical data)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Samples will be analyzed in the 4th quarter of 2024.

Secondary outcomes (3)
  1. Microbiome analysis

    The microbiomes of all groups will be analyzed because it has been described in literature that the microbiome can differ between healthy and obese individuals

    Measured: Microbiome analyses will be performed at the start of 2025

  2. Stress levels

    Assignment of a participant's stress state will be performed based on hair cortisol concentrations, and scores from the Perceived Stress Scale (PSS), the Children's Depression Inventory 2 (CDI-2) and the Rosenberg Self-Esteem Scale (RSES) questionnaires. A summary chronic stress variable will be calculated by adding up the four z-score-transformed variables to give them equal weight

    Measured: 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

  3. Food frequency questionnaire

    To collect data about dietary intakes, participants are provided with an FFQ. Participants are required to indicate the frequency of consumption for each food of interest, ranging from (almost) never, to a few times a week, (almost) daily, to multiple times a day. All responses are encoded into numerical values, representing the frequency of consumption for specific foods.

    Measured: FFQ data are being analyzed continuously and will be finished when the sample collection is finished (estimated by the end of 2024)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2024
  2. Study start11 Jan 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
750 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391671
Sponsor's protocol ID
BC-10583
Acronym
FAME
Status last verified
Apr 2024
First submitted
19 Apr 2024
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Obesity, run by University Ghent at 7 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emile Callemeyn, Dr (+32473271636, emile.callemeyn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolomics (time frame: Samples will be analyzed in the 4th quarter of 2024.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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