[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546462":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":77,"studyPopulation":65,"armGroups":78,"interventions":91,"overallOfficials":100,"centralContacts":105,"locations":110,"responsibleParty":128,"collaborators":65,"id":130,"slug":65,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":65,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":113,"whyStopped":65,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Institut Investigacio Sanitaria Pere Virgili","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":37,"otherOutcomes":65},[9,13,16,19,22,25,28,31,34],{"measure":10,"description":11,"timeFrame":12},"Anthropometric measurements (I)","Changes in weight (kg)","Before and after (12 weeks) of the intervention",{"measure":14,"description":15,"timeFrame":12},"Anthropometric measurements (II)","Changes in body mass index (kg\u002Fm\\^2);",{"measure":17,"description":18,"timeFrame":12},"Anthropometric measurements (III)","Changes waist circumference (cm)",{"measure":20,"description":21,"timeFrame":12},"Anthropometric measurements (IV)","Changes hip circumference (cm)",{"measure":23,"description":24,"timeFrame":12},"Anthropometric measurements (V)","Changes neck circumference (cm)",{"measure":26,"description":27,"timeFrame":12},"Body composition (I)","Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)",{"measure":29,"description":30,"timeFrame":12},"Body composition (II)","Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)",{"measure":32,"description":33,"timeFrame":12},"Body composition (III)","Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)",{"measure":35,"description":36,"timeFrame":12},"Brown fat","Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)",[38,41,44,47,50,53,56,59,62],{"measure":39,"description":40,"timeFrame":12},"Gut and host microbiota-derived metabolites (I)","Changes in circulating short-chain fatty acids levels \\[µM\\]; assesed by Gas Chromatography-Tandem Mass Spectrometry (GC-MS\u002FMS)",{"measure":42,"description":43,"timeFrame":12},"Gut and host microbiota-derived metabolites (II)","Changes in circulating bile acids levels \\[nM\\]; Liquid Chromatography-Tandem Mass Spectrometry (LC-MS\u002FMS)",{"measure":45,"description":46,"timeFrame":12},"Gut and host microbiota-derived metabolites (III)","Changes in circulating succinate levels \\[µM\\]; assesed by EnzyChrom™ Succinate Assay Kit",{"measure":48,"description":49,"timeFrame":12},"Entero-endocrine incretin hormones (I)","Changes in post-prandial response to a meal-tolerance test in serum levels of glucose \\[mg\u002FdL\\]; assesed by ELISA kit",{"measure":51,"description":52,"timeFrame":12},"Entero-endocrine incretin hormones (II)","Changes in post-prandial response to a meal-tolerance test in serum levels of insulin levels \\[pmol\u002FL\\] \\]assesed by ELISA kit",{"measure":54,"description":55,"timeFrame":12},"Entero-endocrine incretin hormones (III)","Changes in post-prandial response to a meal-tolerance test in plasma levels of glucagon-like peptite 1 \\[GLP-1 \\] (pmol\u002FL); assesed by ELISA kit",{"measure":57,"description":58,"timeFrame":12},"Entero-endocrine incretin hormones (IV)","Changes in post-prandial response to a meal-tolerance test in plasma levels of gastric inhibitory polypeptide (GIP) \\[pg\u002FmL\\]; assesed by ELISA kit",{"measure":60,"description":61,"timeFrame":12},"Microbial composition\u002Fmetagenomic","Changes in alpha and beta diversity, relative abundance and functional metagenomics; assesed by Ilumina metagenomics",{"measure":63,"description":64,"timeFrame":12},"Cellular energy metabolism","Changes in Cluster of Differentiation 14 positive (CD14+) monocytes isolated from peripheral blood mononuclear cells (PBMCs) will be used for bioenergetics analysis via an extracellular flux analyzer",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":65,"timePerspective":65,"maskingInfo":71},"RANDOMIZED","PARALLEL","Randomized parallel-arm design (n=40) with consecutive 1:1 allocation to either a continuous calorie restriction diet (n=20) for a healthy Mediterranean diet or an early time-restricted eating protocol + continuous caloric restriction (n=20) over 12 weeks.","TREATMENT",{"masking":72,"maskingDescription":73,"whoMasked":74},"DOUBLE","triple-blind: participants, intervention researchers - except for the nutritionist in charge of diet and lifestyle counseling - and data analysts will be blinded.",[75,76],"INVESTIGATOR","OUTCOMES_ASSESSOR","The specific objectives are:\n\n1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.\n2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.\n3. Define the \"digital footprint\" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.\n\nThe study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.",[79,85],{"label":80,"type":81,"description":82,"interventionNames":83},"Continuous caloric restriction","ACTIVE_COMPARATOR","Continuous calorie restriction diet based on healthy Mediterranean diet recommendations",[84],"Behavioral: Active Comparator: Continuous calorie restriction",{"label":86,"type":87,"description":88,"interventionNames":89},"eTRE","EXPERIMENTAL","early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations",[90],"Behavioral: eTRE",[92,97],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":65},"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",[80],{"type":93,"name":86,"description":98,"armGroupLabels":99,"otherNames":65},"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",[86],[101],{"name":102,"affiliation":103,"role":104},"Juan José Vendrell Ortega, Professor","Instituto de Investigación Sanitaria Pere Virgili (IISPV)","PRINCIPAL_INVESTIGATOR",[106],{"name":102,"role":107,"phone":108,"phoneExt":65,"email":109},"CONTACT","+34 619672912","jvortega2002@gmail.com",[111],{"facility":112,"status":113,"city":114,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"Hospital Universitario de Tarragona Juan XXIII","RECRUITING","Tarragona","43005","Spain","ES",{"type":119,"coordinates":120},"Point",[121,122],1.24544,41.11905,{"lat":122,"lon":121},[125],{"name":126,"role":107,"phone":127,"phoneExt":65,"email":109},"Juan Jose Vendrell Ortega, PhD, MD, Professor","+34 977295800",{"type":129,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","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":142,"type":143},60,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149],"Obesity",[151,152,153,154,155,156,157,158],"obesity","extracellular vesicles","incretins","bile acids","short-chain fatty acids","time-restricted feeding","caloric restriction","brown fat","2024-10-03",{"date":161,"type":162},"2024-10-04","ACTUAL",{"date":164,"type":162},"2024-05-20",{"date":166,"type":143},"2025-12-20",{"name":5,"class":6},1]