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

N/ANot Yet RecruitingNCT06355544

Integrative Phenomics3,000 enrolled

Overview

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.

Cardiometabolic diseases (CMDs) are a heterogeneous spectrum of nutrition-related chronic diseases, ranging from obesity to diabetes and, ultimately, to acute and chronic cardiovascular diseases. Once established, these diseases are usually irreversible and evolve over time. Since these diseases are born out of societal and lifestyle changes, the cornerstones of prevention and management are changes in nutrition and lifestyle. This inevitable increase in CMDs, including obesity, particularly affects socially vulnerable populations. The etiology of cardiometabolic diseases is complex and involves environmental, biological and genetic elements. Weight gain is at the heart of these pathologies: it frequently precedes their development or contributes to the progression of these diseases. To this end, even modest weight loss is suggested as an important line of prevention or treatment of cardiometabolic diseases. For example, diabetes remission can be achieved with weight loss and is directly correlated with the amount of weight lost. Despite the beneficial effects of weight loss on preventing the progression of cardiometabolic diseases, maintaining weight loss is difficult, with only 30% of individuals achieving long-term weight loss (5 years). The same is true with the development of anti-obesity treatments (new analogues of glucagon-like peptide 1 (GLP1)); Discontinuation of treatment is accompanied by weight gain. In the case of diabetes, weight gain is associated with the recurrence of previously remitted diabetes. Chronic low-grade inflammation is tightly linked with obesity and a central feature of cardiometabolic diseases and associated diseases. Furthermore, it paves the way for future comorbidities. This inflammation is characterized by a rise of systemic or circulating inflammatory molecules. However, no single cytokine can reflect the inflammatory state seen in cardiometabolic diseases and these systemic factors are highly variable from subject to subject. Recently, combinatorial indexes, using multiple inflammatory markers have been strongly associated with coronary risks and Metabolic alterations. Over the past 10 years, the gut microbiome has become a recognized contributor to our metabolic health. Accumulating evidence has shown that the gut microbiome strongly reflects environmental and lifestyle changes (including nutrition) by altering its diversity and composition as well as its functions by producing molecules that interact with host organs, including the brain. The excess or deficit production of molecules produced by the microbiota, bacterial metabolites (such as trimethylamine oxide (TMAO), Imidazole propionate, branched-chain amino acids (BCAAs), or short-chain fatty acids (SCFAs), etc.) are molecules implicated in the link between the environment, microbiota and metabolic and inflammatory disturbances. Current strong evidence indicates that the gut microbiota is altered early in people with inflammatory diseases that include CMDs. Relationships between the inflammatory component of the diet and the gut microbiome have also been identified. In an effort to predict chronic-low grade inflammation in a real-world population and decipher the relationships between chronic low-grade inflammation and individual factors, comprising lifestyle, diet, behavior, environment, the gut microbiome, and health-related clinical data, the present study recruits a cohort of participants across age, sex, body mass index, and metabolic health spectra. Chronic low-grade inflammation markers of interest will be measured to establish a multi-component index of inflammation relative in the population.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Time frame: Baseline

Secondary Outcomes

Gut microbiome metabolites

Consumption and production in mmol/day assessed through in silico metabolic modeling

Time frame: Baseline

Fasting glucose

Serum glucose in mg/dl

Time frame: Baseline

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

Time frame: Baseline

Stool microbiome functional pathways

Relative abundances of microbiome functional pathways assessed through metagenomics and in silico metabolic modeling

Time frame: Baseline

Systolic blood pressure

mmHg

Time frame: Baseline

Resting heart rate

Beats per minute

Time frame: Baseline

Serum glycated hemoglobin (HbA1c)

Percentage of HbA1c or mmol/L

Time frame: Baseline

Diastolic blood pressure

millimeters mercury (mmHg)

Time frame: Baseline

Height

Centimeters

Time frame: Baseline

Waist circumference

Centimeters

Time frame: Baseline

Neck circumference

Centimeters

Time frame: Baseline

Hip circumference

Centimeters

Time frame: Baseline

Body fat mass

Percentage of bodymass measured by impedance

Time frame: Baseline

Water body mass

Percentage of body mass measured by impedance

Time frame: Baseline

Lean body mass

Percentage of body mass measured by impedance

Time frame: Baseline

Serum fasting low-density lipoprotein

mmol/L

Time frame: Baseline

Fasting serum high-density lipoprotein

mmol/L

Time frame: Baseline

Fasting total serum cholesterol

mmol/L

Time frame: Baseline

Consumption of dietary macronutrients

Dietary macronutrient consumption assessed in g/day from dietary records and food frequency questionnaires

Time frame: Baseline

Consumption of dietary micronutrients

Daily micronutrient consumption (mg/d) assessed by dietary records and food frequency questionnaire

Time frame: Baseline

Consumption of dietary metabolites

Dietary metabolite consumption expressed in mmol/day assessed by dietary records and food frequency questionnaire

Time frame: Baseline

Food item consumption

Consumption of food items in g/day assessed by dietary records and food frequency questionnaires

Time frame: Baseline

Food group consumption

Consumption of food groups in g/day assessed by dietary records and food frequency questionnaires

Time frame: Baseline

Body weight

Kilograms

Time frame: Baseline

Serum Alanine Transaminase (ALT)

Serum Units per Liter (U/L)

Time frame: Baseline

Serum Aspartate Aminotransferase (ALT)

Serum Units per Liter (U/L)

Time frame: Baseline

Serum gamma-glutamyl transferase (GGT)

Serum Units per Liter (U/L)

Time frame: Baseline

Fasting serum triglycerides

mmol/L

Time frame: Baseline

Fasting serum uric acid

mmol/L

Time frame: Baseline

Fasting serum creatinine

mmol/L

Time frame: Baseline

Fasting serum insulin

mmol/L

Time frame: Baseline

Blood hemoglobin

grams per 100 milliliters (g/100ml)

Time frame: Baseline

Blood hematocrit

Percentage (%) of whole blood sample

Time frame: Baseline

Red blood cells

Cell counts in 10\^9 per liter (10\^9/L)

Time frame: Baseline

Red blood cell volume

Mean volume in cubic micrometers (um\^3)

Time frame: Baseline

Hemoglobin relative red blood cell size

Mean relative hemoglobin relative to red blood cell size in percentage

Time frame: Baseline

Mean cell hemoglobin (MCH)

Mass of hemoglobin per red blood cell in picograms (pg)

Time frame: Baseline

Blood platelets

Cell counts expressed in billions/L (10\^9/L)

Time frame: Baseline

White blood cells

Cell counts expressed in billions/L (10\^9/L) and differential

Time frame: Baseline

Perceived quality of life

Self-perceived measurements of mental, physical, emotional, social, and general quality of life, fatigue, energy assessed by questionnaire

Time frame: Baseline

Eating behavior

Self-perceived emotional, uncontrolled, and eating restriction assessed by questionnaire

Time frame: Baseline

Physical activity

Total, leisure, work, and sports physical activity assessed by questionnaire

Time frame: Baseline

Stool consistency

Stool consistency assessed and self-reported by Bristol Stool Scale

Time frame: Baseline

Stress

Self-perceived stress assessed by questionnaire

Time frame: Baseline

Deprivation

Economic, material, and social deprivation assessed by questionnaire

Time frame: Baseline

Sleep

Sleep latency, duration, efficiency, quality, disturbances, and daytime dysfunction assessed by questionnaire

Time frame: Baseline

Sleep apnea

Binary value (yes/no) assessed from questionnaire

Time frame: Baseline

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

Overview

Conditions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts