[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585256":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":33,"locations":44,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":23,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":60,"whyStopped":23,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Time-restricted feeding","EXPERIMENTAL","Women with grade 3 obesity (BMI 40-50 kg\u002Fm²) follow a time-restricted feeding (TRF) pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period.",[13],"Other: Time-restrictred feeding",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-Time restricted feeding","Women with grade 3 obesity (BMI 40-50 kg\u002Fm²) follow a 14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.",[18],"Other: Non-time restricted feeding",{"label":20,"type":21,"description":22,"interventionNames":23},"Control","NO_INTERVENTION","Women with a healthy body weight without any dietary intervention",null,[25,29],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"Time-restrictred feeding","Time-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period",[9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Non-time restricted feeding","14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period",[15],[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Cléo BOURGEOIS","CONTACT","0156095638","+33","cleo.bourgeois@aphp.fr",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Sébastien CZERNICHOW, MD","0156093067","sebastien.czernichow@aphp.fr",[45,58],{"facility":46,"status":47,"city":48,"state":23,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":23},"HEGP - digestive surgery","ACTIVE_NOT_RECRUITING","Paris","75015","France","FR",{"type":53,"coordinates":54},"Point",[55,56],2.3488,48.85341,{"lat":56,"lon":55},{"facility":59,"status":60,"city":48,"state":23,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"HEGP - nutrition department","RECRUITING",{"type":53,"coordinates":62},[55,56],{"lat":56,"lon":55},[65,67,70],{"name":66,"role":36,"phone":42,"phoneExt":38,"email":43},"Sébastien CZERNICHOW",{"name":68,"role":36,"phone":23,"phoneExt":38,"email":69},"Nathalie ALRASSY","nathalie.alrassy@aphp.fr",{"name":66,"role":71,"phone":23,"phoneExt":23,"email":23},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[75],{"name":76,"class":6},"National Research Agency, France","100585256","study-of-the-effects-of-time-restricted-feeding-on-the-immune-function-of-individuals-with-obesity-100585256",false,"NCT06899997","Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity","Exploring the Effects of Time-restricted Feeding on the Immune Function of Obese Individuals: Multi-omic Approach","OBESIMM","Inclusion Criteria:\n\nPatients with obesity\n\n* Women\n* Age 18-64 years\n* Body mass Index between 40-50 kg\u002Fm²\n* Self-reported eating pattern window of more than 14h\n* Three meal eating pattern\n* Stable body weight (less than 10% of current body weight during the last 3 months)\n* Social security affiliation\n* Written consent\n* Good understanding of the French language\n\nLean patients\n\n* Women\n* Age 18-64 years\n* Body mass Index between 18.5-24.9 kg\u002Fm²\n* Self-reported eating pattern window of more than 14h\n* Social security affiliation\n* Written consent\n* Good understanding of the French language\n\nExclusion Criteria:\n\n* Diabetes type I or II\n* Major cardiovascular disease\n* Pregnancy\n* Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors)\n* Use products intended for weight loss\n* Night work shift\n* Past record of malignant tumors\n* Serious liver dysfunction or chronic kidney disease\n* Eating disorders\n* Chronic viral disease (Hepatitis B or C, HIV) or inflammatory systemic diseases (i.e. Crohn's disease, rheumatoid arthritis)\n* Serious cardiovascular or cerebrovascular disease within 6 months before randomization\n* Severe gastrointestinal diseases or gastrointestinal surgery in the 12 months before randomization\n* Under guardianship, curatorship, deprived of liberty\n* Unable or unwilling to sign the informed consent form.\n* Patient on AME (state medical aid)",true,"FEMALE","18 Years","64 Years",{"count":90,"type":91},24,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this randomized trial is to: 1) investigate the immunological landscape of patients with obesity and conduct an in-depth functional characterization of their immune system; and 2) precisely define the effects of time-restricted feeding (TRF) on immune function in patients with obesity; 3) uncover the underlying mechanisms by which TRF modulates the immune system patients with obesity through a multi-omics approach.\n\nThe main questions it aims to answer are: i) what is the underlying cause of impaired immunocompetence in patients with obesity? ii) how nutritional interventions improve the immune function of patients with obesity? Patients with obesity following TRF (8 h eating window ranging from 6-8 am to 14-16 pm) will be compared to patients with obesity without TRF control schedule (14h eating window ranging from 6-8 am to 8-10 pm). In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between 18.5-24.9 kg\u002Fm²) that will not receive any nutritional intervention.\n\nThe following endpoints will be collected: Body weight and composition using Bioelectrical Impedance Analysis, resting energy expenditure (REE) using indirect calorimetry, blood glucose levels using a continuous glucose monitoring (CGM) device, metabolic parameters (fasting blood glucose levels, C-peptide, HbA1c, insulin, HOMA-IR, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hepatic enzymes), and cytokine profile.\n\nBlood and stool, samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses.",[97],"Obesity and Obesity-related Medical Conditions",[99,100],"Obesity","Immune system","2026-04-20",{"date":103,"type":104},"2026-04-23","ACTUAL",{"date":106,"type":104},"2025-11-03",{"date":108,"type":91},"2027-09-15",{"name":5,"class":6},2]