Ketogenic Diet in MASLD-related cACLD (NCT06537466) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ketogenic Diet in MASLD-related cACLD
Italy50 participantsStarted 2024-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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), . .
✕. 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.
✕. Recent significant weight loss ( \> 5 % within previous 6 months)
✕. Presence of large esophageal varices (F2 or F3)