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

Study acronym: KETONASH
StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Secondary endpoints: 17 to 29v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Bologna
27 trials monitored
See 1 trial at risk
Obesity
3,874 trials monitored
See 152 trials at risk
NASH / MASH
687 trials monitored
See 22 trials at risk
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).
Trial Details
NCT Number NCT06308757
Lead Sponsor University of Bologna
Conditions
(from sponsor)		 NASH, NAFLD, Obesity, Liver Fibrosis
Related terms Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Obesity
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov