Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk (NCT06355544) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk
3,000 participantsStarted 2024-04
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Male or female between the ages of 18 and 70 included,
* One of the following two criteria:
* 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.
* Ability to use a mobile phone application on a daily basis (food intake).
* Subject, after being informed of the contents of this study, fully understanding and accepting its purpose; and able to personally sign a written informed consent
Exclusion Criteria:
* Subject with diagnosed inflammatory disease or infection-related inflammation (viral or bacterial) or medical history (viral) within the last 2 months:
* 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
* Viral hepatitis or ongoing viral infection
* Seasonal virus (influenza-like illness)
* Subjects who have taken antibiotics in the last 2 months
* Subject under treatment within the last 2 months of an:
* Antiviral (for HIV, hepatitis, influenza, chickenpox/shingles)
* Oral, topical, or injectable treatment of a drug that modulates the inflammatory response (e.g. Corticosteroid, non-steroidal anti-inflammatory drugs (e.g. ibu…