Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bologna
About this trial
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 criteria
Qualifiers
Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;
Stable weight for more than 6 months with BMI between 30-40 kg/m2;
Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;
Obtained informed consent.
Disqualifiers
BMI <30 or BMI >40
Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM >14 kPa)
Type 1 diabetes mellitus
Model for End-stage Liver Disease (MELD) score >12, AST or ALT ≥5× ULN, HbA1c >9.5%, INR ≥1.4, creatinine >1.5 mg/dl, platelets <100,000/mm3, and total bilirubin >1.5 mg/dl.
Trial design
Treatments tested in this trial
- Very-low-calorie ketogenic diet (VLCKD) with meal replacements
- Mediterranean low-calorie diet (LCD)
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov