Non-Alcoholic Fatty Liver Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 or older who have been diagnosed with NASH (a type of liver disease caused by fat buildup) with signs of liver scarring (fibrosis), confirmed by a tissue sample taken no more than 6 months before joining the trial
- People whose weight has been stable for more than 6 months and whose Body Mass Index (BMI) is between 30 and 40
- People for whom a liver biopsy (a procedure to take a small sample of liver tissue) is considered safe and possible, and who agree to have a second liver biopsy after 12 months to check how the dietary treatment is working
- People who have given their written agreement (informed consent) to take part
Who may not be able to join:
- People with a BMI below 30 or above 40
- People whose liver disease has progressed to cirrhosis (severe scarring), based on tissue sample results or a liver stiffness measurement above 14 kPa
- People with Type 1 diabetes
- People with certain abnormal blood or liver test results, including: a MELD score (a measure of liver disease severity) above 12; liver enzyme levels (AST or ALT) five times or more above the normal range; a blood sugar control marker (HbA1c) above 9.5%; an INR (a blood clotting measure) of 1.4 or higher; creatinine (a kidney marker) above 1.5 mg/dl; platelet count below 100,000/mm³; or total bilirubin above 1.5 mg/dl
- People who have another known chronic liver disease in addition to NASH/NAFLD, such as alcohol-related liver disease, hepatitis B or C, certain autoimmune or bile duct conditions, Wilson's disease, iron overload disease, drug-related liver injury, or a known or suspected liver cancer
- People who have been drinking more than 4 units of alcohol per day (for men) or 2 units per day (for women) on average in the past 6 months, or who have a history of heavy alcohol use in the last 5 years
- People who have previously had, or are planning to have, a liver transplant, weight-loss (bariatric) surgery, removal of part of the small intestine, or a bile-diverting procedure
- People with a history of acute gallbladder inflammation (cholecystitis) or blocked bile ducts (cholangitis)
- People who have used certain medications known to cause fat buildup in the liver within the past 12 months, including long-term steroids (more than 10 days), amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose oestrogens, or valproic acid
- People who have started or changed the dose of certain supplements or medications in the past 3 months, including high-dose Vitamin E (400 IU/day or more), ursodeoxycholic acid, betaine, S-adenosyl methionine, silymarin, or pentoxifylline
- People who have been diagnosed with a psychiatric disorder or an eating disorder
- People with a life expectancy of less than 6 months
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Fabio Piscaglia, University of Bologna
Phone: 0512142214
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change of at least one grade of liver fibrosis; Change of histological features of NASH
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.