Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk

Launched by INTEGRATIVE PHENOMICS · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding low-grade inflammation, which is a mild but persistent inflammation in the body, and how it relates to various health risks, especially for people who are overweight or have obesity. The researchers want to find out if they can predict low-grade inflammation and what factors—like medical history, lifestyle choices, and biological markers—are connected to it. This study is particularly interested in healthy individuals as well as those with certain weight and metabolic conditions.

To participate, you need to be between 18 and 70 years old and meet specific weight criteria. For example, if you are overweight, your Body Mass Index (BMI) should be between 25 and 35, while a healthy weight participant should have a BMI between 18.5 and 25 without any metabolic issues. Participants will attend a medical visit to measure vital signs and provide blood samples, complete questionnaires, and collect a stool sample at home. It's important to note that this study is not yet recruiting participants, so keep an eye out for updates if you think you might be eligible!

Gender

ALL

Eligibility criteria

• 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. ibuprofen, diclofenac, celecoxib, naproxen, aspirin, etc.)
• • Dietary supplement that can modulate the inflammatory response (e.g.
• • Omega 3 fatty acid, curcuma/turmeric, probiotic, prebiotics)
• • Subject with diabetes (type 1 or 2) known treated prior to the inclusion visit (specifically subjects recently diagnosed or diagnosed with diabetes at the time of the laboratory assessment may be retained in the study if they are not taking anti-diabetic treatment): i.e. exclusion of subject with diabetes diagnosed with fasting blood glucose ≥ 126 mg/dL (7.0 mmol measured twice/L OR glycated hemoglobin ≥ 6.5% (48 mmol/mol) AND anti-diabetic therapy (metformin, GLP-1 receptor agonist, insulin, sulphonylurea, alpha-glucosidase inhibitor)
• • Subject with severe or unstable hepatic, renal, cardiovascular, respiratory, endocrine, or metabolic disorders or cancer diagnosed with or without treatment
• • Subject suffering from gastrointestinal disorders resulting in the use of laxatives or drugs for intestinal transit (e.g., loperamide) in the last 2 months.
• • Subject with a complication or procedure in the last 2 months that could result in inflammation
• • Minor or acute tendonitis, sprain, or contusion
• • Severe contusion (e.g. Bone contusion)
• • Major or invasive surgery
• • Subject in a situation that, in the opinion of the investigator, could interfere with optimal participation in the present study or pose a particular risk to the subject.
• • Subject currently participating in an interventional clinical study
• • Subject not affiliated to the Social Security scheme
• • Subject who did not comply with the exclusion period of the study in which they would have previously participated
• • Subject not being able to use the internet