Actively Recruiting
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
Led by University of Bologna · Updated on 2024-03-15
42
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6518 years with histological diagnosis of NASH with evidence of fibrosis obtained no more than 6 months before enrollment
- Stable weight for more than 6 months with BMI between 30-40 kg/m2
- Safe and feasible to proceed with liver biopsy and consent to undergo liver biopsy after 12 months
- Obtained informed consent
You will not qualify if you...
- BMI less than 30 or greater than 40
- Evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM >14 kPa)
- Type 1 diabetes mellitus
- MELD score >12, AST or ALT 655�d7 ULN, HbA1c >9.5%, INR 651.4, creatinine >1.5 mg/dl, platelets <100,000/mm3, and total bilirubin >1.5 mg/dl
- Other known chronic liver diseases beyond MAFLD/NAFLD (alcoholic liver disease, viral hepatitis, cholestatic-autoimmune diseases, Wilson's disease, hemochromatosis, drug-induced liver injury, or hepatocellular carcinoma suspicion)
- Average alcohol consumption exceeding 4 units/day for males or 2 units/day for females in the last 6 months and history of excessive alcohol use in last 5 years
- Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion
- History of acute cholecystitis or biliary obstructions
- Recent or concurrent use of agents causing hepatic steatosis or recent changes in certain liver-related medications
- Presence of psychiatric disorders or eating disorders
- Life expectancy less than 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Fabio Piscaglia, MD, PhD, Professor
CONTACT
F
Federico Ravaioli, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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