protocolSection identificationModule nctId: NCT06355544, orgStudyIdInfo id: PINEAPPL2023, secondaryIdInfos id: 2023-A02494-41, type: OTHER, domain: Agence nationale de sécurité du médicament et des produits de santé, briefTitle: Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk, acronym: PINEAPPL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Integrative Phenomics, class: INDUSTRY, collaborators name: Assistance Publique - Hôpitaux de Paris, collaborators name: Assistance Publique Hopitaux De Marseille, collaborators name: University Hospital, Bordeaux, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: Institut Pasteur de Lille, collaborators name: Hopitaux Civils de Colmar, descriptionModule briefSummary: 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., conditionsModule conditions: Overweight, conditions: Obesity, conditions: Metabolic Syndrome, conditions: Healthy, conditions: Low-grade Inflammation, conditions: Normal Weight Adults, conditions: Risk Factor, Cardiovascular, conditions: Hypertension, conditions: Hypercholesterolemia, conditions: Abdominal Obesity, conditions: Metabolically Healthy Controls, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Low-grade inflammation, secondaryOutcomes measure: Gut microbiome metabolites, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Stool microbiome composition, secondaryOutcomes measure: Stool microbiome functional pathways, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Resting heart rate, secondaryOutcomes measure: Serum glycated hemoglobin (HbA1c), secondaryOutcomes measure: Diastolic blood pressure, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Neck circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body fat mass, secondaryOutcomes measure: Water body mass, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Serum fasting low-density lipoprotein, secondaryOutcomes measure: Fasting serum high-density lipoprotein, secondaryOutcomes measure: Fasting total serum cholesterol, secondaryOutcomes measure: Consumption of dietary macronutrients, secondaryOutcomes measure: Consumption of dietary micronutrients, secondaryOutcomes measure: Consumption of dietary metabolites, secondaryOutcomes measure: Food item consumption, secondaryOutcomes measure: Food group consumption, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Serum Alanine Transaminase (ALT), secondaryOutcomes measure: Serum Aspartate Aminotransferase (ALT), secondaryOutcomes measure: Serum gamma-glutamyl transferase (GGT), secondaryOutcomes measure: Fasting serum triglycerides, secondaryOutcomes measure: Fasting serum uric acid, secondaryOutcomes measure: Fasting serum creatinine, secondaryOutcomes measure: Fasting serum insulin, secondaryOutcomes measure: Blood hemoglobin, secondaryOutcomes measure: Blood hematocrit, secondaryOutcomes measure: Red blood cells, secondaryOutcomes measure: Red blood cell volume, secondaryOutcomes measure: Hemoglobin relative red blood cell size, secondaryOutcomes measure: Mean cell hemoglobin (MCH), secondaryOutcomes measure: Blood platelets, secondaryOutcomes measure: White blood cells, secondaryOutcomes measure: Perceived quality of life, secondaryOutcomes measure: Eating behavior, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Stool consistency, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Deprivation, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Sleep apnea, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False