[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475921":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":56,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":20,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":20,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention arm with VLCKD","EXPERIMENTAL","all patients will receive a very low calorie Ketogenic diet (VLCKD) and will be followed for all the time of the study, monitoring gut permeability, liver steatosis and microbiome composition",[13],"Dietary Supplement: Ketogenic Diet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Ketogenic Diet","all patients will receive a very low calorie ketogenic diet",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Giovanni De Pergola, Prof","IRCCS \"Saverio de Bellis\"","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Giovanni De Perogla, Prof","CONTACT","0804994635","giovanni.depergola@irccsdebellis.it",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Irccs Saverio de Bellis","RECRUITING","Castellana Grotte","BARI","70013","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],17.16549,40.88643,{"lat":45,"lon":44},[48,50],{"name":49,"role":29,"phone":30,"phoneExt":20,"email":31},"Giovanni De Pergola, Professor",{"name":51,"role":29,"phone":30,"phoneExt":20,"email":52},"Sara De Nucci, Dr","sa.denucci@gmail.com",{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Prof. Giovanni De Pergola, MD","Professor",[57,60,62,64,66,68,70,72,74,76,78,80,82,84],{"name":58,"class":59},"Francesco Russo","UNKNOWN",{"name":61,"class":59},"Giuseppe, Riezzo",{"name":63,"class":59},"Michele, Linsalata",{"name":65,"class":59},"Antonella, Orlando",{"name":67,"class":59},"Benedetta, D Attoma",{"name":69,"class":59},"Laura, Prospero",{"name":71,"class":59},"Antonia, Ignazzi",{"name":73,"class":59},"Sara, De Nucci",{"name":75,"class":59},"Raffaele, Cozzolongo",{"name":77,"class":59},"Vito, Giannuzzi",{"name":79,"class":59},"Maria, De Angelis",{"name":81,"class":59},"Giusy Rita, Caponio",{"name":83,"class":59},"Oronzo, Milella",{"name":85,"class":59},"Gianluigi, Giannelli","100475921","evaluation-of-gut-permeability-in-patients-affected-by-obesity-and-nafld-influence-of-ketogenic-diet-100475921",false,"NCT05477212","Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet.","Evaluation of Gut Permeability in Patients Affected by Obesity and NAFLD: Influence of Ketogenic Diet on Diagnostic and Prognostic Markers in Liver Disease","Inclusion Criteria:\n\n1. BMI ≥ 30 Kg\u002Fm2 or abdominal circumference (waist) \\>94 cm in men and \\>80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the features that characterize the metabolic syndrome\n2. Age range between 18 and 70 years, both sexes\n3. Diagnosis of hepatic steatosis, formulated on the basis of fibroscan \\[CAP (controlled attenuation parameter) \\> 238 dB\u002Fm(decibel\u002Fmeter)\\], and other recognized criteria (FLI - Fatty Liver Index , FIB-4 - Fibrosis-4 index, NFS - NAFLD fibrosis score).\n\nExclusion Criteria:\n\n1. Normal and underweight subjects\n2. Presence of any pathology that may affect the presence of altered intestinal permeability or steatosis, apart from pathologies that represent inclusion criteria\n3. Treatment with any device, pharmacological or not, that can affect intestinal permeability and liver metabolism and, therefore, the presence of steatosis\n4. Pregnancy or lactation","ALL","18 Years","65 Years",{"count":97,"type":98},30,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis.\n\nThe first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis.\n\nIntestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body.\n\nThe second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis",[104,105,106],"Permeability; Increased","NAFLD","Obesity",[108,109,105,110],"obesity","Gut permeability","Ketogenic diet","2024-10-01",{"date":113,"type":114},"2024-10-02","ACTUAL",{"date":116,"type":114},"2022-04-28",{"date":118,"type":98},"2025-05-28",{"name":5,"class":6},1]