[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539816":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":76,"collaborators":26,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VLCKD arm","EXPERIMENTAL","The VLCKD dietary intervention consists of five phases:\n\nKetogenic Low-Calorie Period (2 months):\n\n* Phase 1 (30 days - Visits 1-3): Ketogenic diet with low-fat content, 600 kcal\u002Fday.\n* Phase 2 (15 days - Visit 5): 660 kcal\u002Fday.\n* Phase 3 (15 days - Visit 5): 730 kcal\u002Fday\n\nLow-Calorie Period (2 months):\n\nPhase 4 (30 days - Visits 6-7): Hypocaloric diet with the reintroduction of different foods, 1,050 kcal\u002Fday.\n\n\\- Phase 5 (30 days - Visits 7-8): 1,400 kcal\u002Fday.\n\nDuring these phases, the patient will receive nutritional supplementation with vitamins, trace elements, and omega-3 fatty acids. Throughout the very low-calorie ketogenic period, the patient will have three interim dietetic consultations (Visits 2-4) and a medical visit (Visit 5). During the low-calorie period, the patient will receive alternating two dietetic consultations (Visits 6 and 7) and one medical visit every 30 days (Visit 8).",[13],"Dietary Supplement: Very-low-calorie ketogenic diet (VLCKD) with meal replacements",{"label":15,"type":16,"description":17,"interventionNames":18},"Control LCD arm","ACTIVE_COMPARATOR","The control LCD arm consists of a diet with natural low-calorie foods (1200-1500 kcal\u002Fday or a reduction of 500-1000 kcal\u002Fday compared to baseline) and a low glycemic index based on the \"Mediterranean Diet\" model, following the most recent guidelines on MAFLD\u002FNAFLD. Similar to the VLCKD arm, for the entire duration of the dietetic treatment, the patient will alternately receive dietetic consultations and medical visits.\n\nAt the end of the dietary intervention, patients from both study arms will continue with a controlled, low glycemic index diet tailored to the patient's basal metabolic rate (BMR) (estimated with bioimpedance assessment) for an additional six months.\n\nBoth study arms will follow a physical activity schedule and will have psychological-motivational support.",[19],"Dietary Supplement: Mediterranean low-calorie diet (LCD)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Very-low-calorie ketogenic diet (VLCKD) with meal replacements","The VLCKD study arm will receive an experimental diet therapy with very-low-calorie ketogenic meal replacements (VLCKD) consisting of 5 successive phases (600 - 1500 kcal\u002Fday).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mediterranean low-calorie diet (LCD)","The Control arm LCD will receive standard Mediterranean type low-calorie diet (LCD) therapy by the most recent guidelines on MAFLD\u002FNAFLD (1200-1500 kcal\u002Fday).",[15],[32],{"name":33,"affiliation":5,"role":34},"Fabio Piscaglia","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Fabio Piscaglia, MD, PhD, Professor","CONTACT","0512142214","fabio.piscaglia@unibo.it",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Federico Ravaioli, MD, PhD","+393333176759","f.ravaioli@unibo.it",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","RECRUITING","Bologna","40138","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],11.33875,44.49381,{"lat":57,"lon":56},[60,62,66,68,70,72,74],{"name":61,"role":38,"phone":43,"phoneExt":26,"email":44},"Federico Ravaioli",{"name":63,"role":38,"phone":64,"phoneExt":26,"email":65},"Sofia Penazza","0512142477","sofia.penazza2@unibo.it",{"name":42,"role":67,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":69,"role":67,"phone":26,"phoneExt":26,"email":26},"Maria Letizia Petroni, Professor",{"name":71,"role":34,"phone":26,"phoneExt":26,"email":26},"Fabio Piscaglia, Professor",{"name":73,"role":67,"phone":26,"phoneExt":26,"email":26},"Silvia Ferri, MD",{"name":75,"role":67,"phone":26,"phoneExt":26,"email":26},"Simona Leoni, MD",{"type":34,"investigatorFullName":33,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor","100539816","role-of-the-very-low-calorie-ketogenic-diet-vlckd-in-patients-with-non-alcoholic-steatohepatitis-nash-with-fibrosis-100539816",false,"NCT06308757","Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis","The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)","KETONASH","Inclusion Criteria:\n\n* Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;\n* Stable weight for more than 6 months with BMI between 30-40 kg\u002Fm2;\n* Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;\n* Obtained informed consent.\n\nExclusion Criteria:\n\n* BMI \\\u003C30 or BMI \\>40\n* Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM \\>14 kPa)\n* Type 1 diabetes mellitus\n* Model for End-stage Liver Disease (MELD) score \\>12, AST or ALT ≥5× ULN, HbA1c \\>9.5%, INR ≥1.4, creatinine \\>1.5 mg\u002Fdl, platelets \\\u003C100,000\u002Fmm3, and total bilirubin \\>1.5 mg\u002Fdl.\n* Concurrent presence of any other known chronic liver disease beyond MAFLD\u002FNAFLD, such as alcoholic liver disease, viral (HCV\u002FHBV), cholestatic-autoimmune (PBC\u002FPSC\u002FAIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC);\n* Average alcohol consumption exceeding 4\u002F2 units\u002Fday (males\u002Ffemales) in the preceding 6 months and a history of excessive alcohol consumption in the last 5 years;\n* Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion;\n* History of acute cholecystitis and biliary obstructions (cholangitis);\n* Recent (in the last 12 months) or concurrent use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose estrogens, valproic acid);\n* Recent (in the last 3 months) change in the dose\u002Fregimen or introduction of Vitamin E (at doses ≥400 IU\u002Fday), ursodeoxycholic acid (UDCA), betaine, S-adenosyl methionine, silymarin, or pentoxifylline;\n* Presence of psychiatric disorders and\u002For diagnosis of any eating disorder;\n* Life expectancy \\\u003C6 months.","ALL","18 Years",{"count":89,"type":90},42,"ESTIMATED","INTERVENTIONAL",[93],"NA","The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver\u002FEuropean Society for Clinical Nutrition and Metabolism guidelines on MAFLD\u002FNAFLD).",[96,97,98,99],"NASH","NAFLD","Obesity","Liver Fibrosis",[101,102,103],"vlckd","diet","ketogenic diet","2024-03-13",{"date":106,"type":107},"2024-03-15","ACTUAL",{"date":109,"type":107},"2021-09-29",{"date":111,"type":90},"2026-12-12",{"name":5,"class":6},1]