About this trial
The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.
The main questions it aims to answer are:
* Whether it is possible to predict low-grade inflammation * What are the medical, biological, and lifestyle variables related to low-grade inflammation?
Participants will be asked to:
1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples. 2. Complete questionnaires and collect a stool sample at home.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female between the ages of 18 and 70 included,
Clinically at-risk group Body Mass Index between 25 (included) and up to 35 kg/m2 (excluded)
Non-clinically at-risk group Body Mass Index between 18.5 (included) and up to 25 kg/m2 (excluded) and absence of metabolic syndrome criteria
Subject covered by social security or a similar system.
Disqualifiers
Rheumatoid arthritis, reactive or psoriatic arthritis (non-osteoarthritis)
Inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis) or irritable bowel syndrome
Systemic lupus erythematosus
Uncontrolled psoriasis
Trial population
Existing or new patients with overweight or obesity from primary care at La Pitié-Salpetriere Hospital in Paris, Marseille Public Hospital, Colmar Civil Hospital, Bordeaux University Hospital. Healthy volunteers throughout France.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Low-grade inflammation
Assessed as a z-score composed of six markers (C reactive protein (CRP), interleukin (IL)-6, serum amyloid-A (SAA), soluble intracellular adhesion molecule (sICAM), tumor necrosis factor alpha (TNF)-alpha) and categorized into 3 tertiles: Low/ Moderate/High
Secondary outcomes
Gut microbiome metabolites
Consumption and production in mmol/day assessed through in silico metabolic modeling
Fasting glucose
Serum glucose in mg/dl
Stool microbiome composition
Relative abundance of microbiome taxonomies (Phyla, Order, Class, Family, Genus, Species), metagenomic species (MGS), and co-abundance genes (CAGs) in stool samples assessed through shot-gun sequencing
Stool microbiome functional pathways
Relative abundances of microbiome functional pathways assessed through metagenomics and in silico metabolic modeling
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Integrative Phenomics
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
Assistance Publique Hopitaux De Marseille
Collaborator
University Hospital, Bordeaux
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
Institut Pasteur de Lille
Collaborator
Hopitaux Civils de Colmar
Collaborator
This trial is not recruiting at the moment. You can still explore other options: