[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546462":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous caloric restriction","ACTIVE_COMPARATOR","Continuous calorie restriction diet based on healthy Mediterranean diet recommendations",[13],"Behavioral: Active Comparator: Continuous calorie restriction",{"label":15,"type":16,"description":17,"interventionNames":18},"eTRE","EXPERIMENTAL","early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations",[19],"Behavioral: eTRE",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Active Comparator: Continuous calorie restriction","Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention",[15],[31],{"name":32,"affiliation":33,"role":34},"Juan José Vendrell Ortega, Professor","Instituto de Investigación Sanitaria Pere Virgili (IISPV)","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+34 619672912","jvortega2002@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hospital Universitario de Tarragona Juan XXIII","RECRUITING","Tarragona","43005","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],1.24544,41.11905,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":26,"email":39},"Juan Jose Vendrell Ortega, PhD, MD, Professor","+34 977295800",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100546462","circulating-microvesicles-regulating-metabolic-homeostasis-in-obesity-after-caloric-restriction-programs-100546462",false,"NCT06395246","Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs","The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating","TREV","Inclusion Criteria:\n\n1. age between 18 and 70 years old.\n2. BMI ranges between 27 and 40 kg\u002F m2.\n3. Absence of underlying pathology in medical and physical examination, except for those related to excess weight.\n4. Signature of the informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.\n2. Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma).\n3. Pregnancy and lactation.\n4. Vegetarians or subjects subjected to an irregular diet.\n5. Patients with severe eating disorders.\n6. Patients with clinical symptoms and signs of infection in the previous month.\n7. Patients with chronic anti-inflammatory steroid treatments and\u002For nonsteroidal anti-inflammatory drugs.\n8. Recent antibiotic treatment.\n9. Uncontrolled alcoholism or drug abuse.\n10. Rotating or nocturnal shift workers.",true,"ALL","18 Years","70 Years",{"count":73,"type":74},60,"ESTIMATED","INTERVENTIONAL",[77],"NA","The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.",[80],"Obesity",[82,83,84,85,86,87,88,89],"obesity","extracellular vesicles","incretins","bile acids","short-chain fatty acids","time-restricted feeding","caloric restriction","brown fat","2024-10-03",{"date":92,"type":93},"2024-10-04","ACTUAL",{"date":95,"type":93},"2024-05-20",{"date":97,"type":74},"2025-12-20",{"name":5,"class":6},1]