protocolSection identificationModule nctId: NCT06308757, orgStudyIdInfo 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-29, primaryCompletionDateStruct date: 2024-11-24, completionDateStruct date: 2026-12-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule 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)., conditionsModule conditions: NASH, conditions: NAFLD, conditions: Obesity, conditions: Liver Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Two-arms, 2: 1 randomization stratified by type 2 diabetes mellitus and gender, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Very-low-calorie ketogenic diet (VLCKD) with meal replacements, interventions name: Mediterranean low-calorie diet (LCD), outcomesModule primaryOutcomes measure: Change of at least one grade of liver fibrosis, primaryOutcomes measure: Change of histological features of NASH, secondaryOutcomes measure: Histological NIH NASH CRN Score, secondaryOutcomes measure: Histological FLIP/SAF changes, secondaryOutcomes measure: Biochemical test changes 1, secondaryOutcomes measure: Biochemical test changes 2, secondaryOutcomes measure: Biochemical test changes 3, secondaryOutcomes measure: Biochemical test changes 4, secondaryOutcomes measure: Biochemical test changes 5, secondaryOutcomes measure: Biochemical test changes 6, secondaryOutcomes measure: Biochemical test changes 7, secondaryOutcomes measure: Biochemical test changes 8, secondaryOutcomes measure: Biochemical test changes 9, secondaryOutcomes measure: Biochemical test changes 10, secondaryOutcomes measure: Biochemical test changes 11, secondaryOutcomes measure: Biochemical test changes 12, secondaryOutcomes measure: Biochemical test changes 13, secondaryOutcomes measure: Fibrosis-4 test (FIB-4 ) variation, secondaryOutcomes measure: NAFLD Fibrosis Score (NFS) change, secondaryOutcomes measure: FAST (FibroScan-AST) score variation, secondaryOutcomes measure: Fatty Liver Index (FLI) modification, secondaryOutcomes measure: Changes in LSM, secondaryOutcomes measure: Variation of steatosis by CAP, secondaryOutcomes measure: Body Mass Index (BMI) improvement, secondaryOutcomes measure: Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale), secondaryOutcomes measure: Compliance to VLCKD evaluated by VAS (Visual Analogue Scale), secondaryOutcomes measure: Variation of steatosis by ultrasound assessment, secondaryOutcomes measure: Questionnaires 1, secondaryOutcomes measure: Questionnaires 2, secondaryOutcomes measure: Questionnaires 3, secondaryOutcomes measure: Questionnaires 4, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, status: RECRUITING, city: Bologna, zip: 40138, country: Italy, contacts name: Federico Ravaioli, role: CONTACT, phone: +393333176759, email: f.ravaioli@unibo.it, contacts name: Sofia Penazza, role: CONTACT, phone: 0512142477, email: sofia.penazza2@unibo.it, contacts name: Federico Ravaioli, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Maria Letizia Petroni, Professor, role: SUB_INVESTIGATOR, contacts name: Fabio Piscaglia, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: Silvia Ferri, MD, role: SUB_INVESTIGATOR, contacts name: Simona Leoni, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, documentSection largeDocumentModule largeDocs 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, largeDocs 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