Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391671
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-19
Brief Title:
The Stress-obesity Axis a Metabolomics Approach Towards Personalized Nutrition in Adolescents
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
The Stress-obesity Axis a Metabolomics Approach Towards Personalized Nutrition in Adolescents FAME
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAME
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 andor prognostic potential Additionally microbiome analysis will be performed to map the microbiome of all groups
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 andor prognostic potential Additionally microbiome analysis will be performed to map the microbiome of all groups
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 overweightobesity 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 participants 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 WP12 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 overweightobesity group In our 3-month personalized intervention separate menus for each participant will be prepared by our dietician Based on WP12 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 -80C 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
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 WP12 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 overweightobesity group In our 3-month personalized intervention separate menus for each participant will be prepared by our dietician Based on WP12 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 -80C 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None