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

NCT06355544 | Not Yet Recruiting

• 2 other identifiers: PINEAPPL20232023-A02494-41
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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:
• Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.
• Complete questionnaires and collect a stool sample at home.

Conditions

Overweight; Obesity; Metabolic Syndrome; Healthy; Low-grade Inflammation; Normal Weight Adults; Risk Factor, Cardiovascular; Hypertension; Hypercholesterolemia; Abdominal Obesity; Metabolically Healthy Controls

Keywords

nutrition; microbiome; lifestyle factors; low-grade inflammation; personalized nutrition; precision nutrition

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (47)

• Gut microbiome metabolites

  Baseline

• Fasting glucose

  Baseline

• Stool microbiome composition

  Baseline

• Stool microbiome functional pathways

  Baseline

• Systolic blood pressure

  Baseline

Study Arms (2)

Not clinically at-risk

Individuals with BMI between 18.5 kg/m2 (included) and 25 kg/m2 (excluded) and without risk factors for metabolic syndrome

Clinically at-risk

Individuals with BMI between 25 (included) and 35 kg/m2 (excluded) with or without metabolic syndrome and without treated type-2 diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Integrative Phenomics: lead
• 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples, stool samples

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Hypertension; Hypercholesterolemia; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Central Study Contacts

Karine Clément, MD, PhD

CONTACT

33142177031; karine.clement@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04