Clinical Research Directory

LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

The goal of this clinical trial is to compare food for special medical purposes (Aminolife Plus, by Piemme Pharmatech) vs. placebo in improving muscle mass and function in a cohort of cirrhotic patients. The main questions it aims to answer are: * whether functional ability improves in cirrhotic-sarcopenic patients two months after taking the supplement compared with those not taking the supplement. * whether weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle as per bioimpedance analysis (BIA) in cirrhotic-sarcopenic patients increase two months after taking the supplement compared with those not taking the supplement. * to assess quality-of-life indices in the two groups. * to assess differences in groups in terms of plasma metabolite production in the two groups This is a spontaneous, no PROFIT, pilot interventional study in the form of a randomized clinical trial (RCT), double-blind. All patients will undergo simple sarcopenia risk identification questions (SARC-F test). All patients recognized to be at risk will be randomized to receive. 1. nutritional counseling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs. 2. nutritional counseling according to guidelines + placebo 20 g/day (4 scoops) for a total of 60 days (2 months). The manufacturing company will provide the product and placebo free of charge. Patients will undergo, at the first visit and at the follow-up visit anthropometric measurements and body composition assessment (by bioimpedance analysis). In addition, 1 blood sample for metabolomic analysis will be taken at the same visits. The study will last 12 months.

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