Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
Condition(s) studied
Investigational drug(s) / intervention(s)
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/day).
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/NAFLD (1200-1500 kcal/day).
Study 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).
Eligibility
Primary outcome measure(s)
- Change of at least one grade of liver fibrosis — 12 months
Histological change of liver fibrosis without worsening of NASH - Change of histological features of NASH — 12 months
NASH parameters variation. Improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥1 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Italy | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06308757 on ClinicalTrials.gov ↗ ← All trials in Italy