Ketogenic Diet Versus Mediterranean Diet in Adults With Fatty Liver Cirrhosis
Compares a very low carbohydrate diet with a Mediterranean diet in adults with cirrhosis.
Plain-language title generated from the registry record
Registry title: Ketogenic Diet in MASLD-related cACLD
Key facts
- Where
- Palermo, ItalySee the site
Where in Italy
- Section of Gastroenterology, PROMISE, University of PalermoPalermo, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Palermo
- Trial code
- NCT06537466
- Record updated
- 5 August 2024
- Original description
The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.Read full original descriptionShow less
A Randomised Controlled Tria of Low-calorie Ketogenic Diet Versus Mediterranean Diet in Patients With Compensated Advanced Chronic Liver Disease (cACLD) Secondary to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.
Inclusion: Patients older than 18 years; Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and/or fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor; Informed consent form obtained before any trial-related ac.vity.
Exclusion: Recent significant weight loss ( \> 5 % within previous 6 months); Therapy with SGLT-2 inhibitors and/or GLP-1 agonist started within 6 months of screening visit; Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid); MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively; History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention; Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis; Any additional condition that might interfere with optimal participation in the study, according to investigators opinion; Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA\<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \<1:160), . ; Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\<30 ml/min); Presence of large esophageal varices (F2 or F3); Be pregnant or breasxeeding.