[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563411":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":34,"collaborators":12,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":12,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":63,"whyStopped":12,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":12},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group - Mediterranean diet with low glycemic index","NO_INTERVENTION","Control group in which patients will follow a Mediterranean diet with a low glycemic index",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Case group - Intermittent Fasting","EXPERIMENTAL","Intermittent fasting 14\u002F10 with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet.",[18],"Dietary Supplement: Intermittent Fasting",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIETARY_SUPPLEMENT","Intermittent Fasting","In this group, a diet based on intermittent fasting will be administered - with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Rosa Reddavide, Biologyst","CONTACT","0804994387","rosa.reddavide@irccsdebellis.it",{"name":32,"role":28,"phone":12,"phoneExt":12,"email":33},"Ornella Rotolo, Biologyst","ornella.rotolo@irccsdebellis.it",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Dr. Rosa Reddavide - MSc","Principal Investigator, Biologyst","100563411","intermittent-fasting-mediterranean-diet-and-nafld-100563411",false,"NCT06615817","Intermittent Fasting, Mediterranean Diet and NAFLD","Comparison Between 14\u002F10 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score, Inflammatory Indices and Intestinal Microbiota","RC2024-21","Inclusion Criteria:\n\n* Medium\u002Fsevere NAFLD (CAP\\>268)\n* BMI between 25 and 35\n\nExclusion Criteria:\n\n* diabetes treated with insulin,\n* fatty liver disease linked to alcohol consumption,\n* chronic inflammatory intestinal and oncological diseases,\n* visceral obesity which does not allow good resolution of Fibroscan images,\n* subjects in serious medical conditions that may compromise participation in the trial,\n* people following a special diet or unable to follow a diet for religious or other reasons.\n* Pregnancy and breastfeeding",true,"ALL","30 Years","65 Years",{"count":51,"type":52},60,"ESTIMATED","INTERVENTIONAL",[55],"NA","This study aims to evaluate the effects of Intermittent Fasting (IF) 14\u002F10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.",[58,59,22,60],"NAFLD","Obesity","Mediterranean Diet",[59,62],"Liver Diseases","NOT_YET_RECRUITING","2024-10-22",{"date":66,"type":67},"2024-10-26","ACTUAL",{"date":69,"type":52},"2025-01-01",{"date":71,"type":52},"2027-01-01",{"name":5,"class":6}]