Clinical Trial

Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis

Study acronym: KETONASH
Recruiting
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Record status
This record was last updated March 15, 2024 (before its estimated November 24, 2024 completion). Its status may not reflect the trial's current state.
Summary
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-05.
Trial Details
NCT Number NCT06308757
Lead Sponsor University of Bologna
Conditions NASH, NAFLD, Obesity, Liver Fibrosis
Enrollment 42 participants
Start Date 2021-09-29
Primary Completion 2024-11-24 (estimated)
Study Completion 2026-12-12 (estimated)
Updated on ClinicalTrials.gov 2024-03-15