nctId: NCT06308757 id: 495/2021/Sper/AOUBo briefTitle: Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis acronym: KETONASH overallStatus: RECRUITING date: 2021-09-29 date: 2024-11-24 date: 2026-12-12 date: 2024-03-13 date: 2024-03-15 name: University of Bologna class: OTHER briefSummary: 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/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD). conditions: NASH conditions: NAFLD conditions: Obesity conditions: Liver Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use primaryPurpose: TREATMENT masking: NONE maskingDescription: Two-arms, 2: 1 randomization stratified by type 2 diabetes mellitus and gender count: 42 type: ESTIMATED name: Very-low-calorie ketogenic diet (VLCKD) with meal replacements name: Mediterranean low-calorie diet (LCD) measure: Change of at least one grade of liver fibrosis measure: Change of histological features of NASH measure: Histological NIH NASH CRN Score measure: Histological FLIP/SAF changes measure: Biochemical test changes 1 measure: Biochemical test changes 2 measure: Biochemical test changes 3 measure: Biochemical test changes 4 measure: Biochemical test changes 5 measure: Biochemical test changes 6 measure: Biochemical test changes 7 measure: Biochemical test changes 8 measure: Biochemical test changes 9 measure: Biochemical test changes 10 measure: Biochemical test changes 11 measure: Biochemical test changes 12 measure: Biochemical test changes 13 measure: Fibrosis-4 test (FIB-4 ) variation measure: NAFLD Fibrosis Score (NFS) change measure: FAST (FibroScan-AST) score variation measure: Fatty Liver Index (FLI) modification measure: Changes in LSM measure: Variation of steatosis by CAP measure: Body Mass Index (BMI) improvement measure: Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale) measure: Compliance to VLCKD evaluated by VAS (Visual Analogue Scale) measure: Variation of steatosis by ultrasound assessment measure: Questionnaires 1 measure: Questionnaires 2 measure: Questionnaires 3 measure: Questionnaires 4 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna status: RECRUITING city: Bologna zip: 40138 country: Italy name: Federico Ravaioli role: CONTACT phone: +393333176759 email: f.ravaioli@unibo.it name: Sofia Penazza role: CONTACT phone: 0512142477 email: sofia.penazza2@unibo.it name: Federico Ravaioli, MD, PhD role: SUB_INVESTIGATOR name: Maria Letizia Petroni, Professor role: SUB_INVESTIGATOR name: Fabio Piscaglia, Professor role: PRINCIPAL_INVESTIGATOR name: Silvia Ferri, MD role: SUB_INVESTIGATOR name: Simona Leoni, MD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-23 uploadDate: 2024-02-19T03:31 filename: Prot_SAP_000.pdf size: 368757 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-14 uploadDate: 2024-02-19T03:32 filename: ICF_001.pdf size: 47308 hasResults: False