LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
NCT Number: NCT06573229
Acronym: LIFRAMIN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sarcopenia|Cirrhosis, Liver|Malnutrition; Protein
Interventions: DIETARY_SUPPLEMENT: Aminolife Plus by Piemme Pharmatech, Italy
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-02
Completion Date: 2025-02-28
Locations: Emanuele Rinninella, Rome, 00168, Italy

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.

Primary Outcome Measures: Improved functional capacity (Liver Frailty Index), Improved functional capacity in cirrhotic-sarcopenic patients, assessed by using the Liver Frailty Index test, which has already been validated in the literature and includes 3 continuous parameters (Handgrip strenght test, Chair Stand Test and Balance test)., 12 months
Secondary Outcome Measures: Improved anthropometric and bioelectrical values, Differences between the two groups in weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle, as per bioimpedance analysis (BIA);, 12 months|Improved QoL, Differences in quality of life indices (QLQ-C30, QLQ-CR29, QLQ-CAX24, QLQ-PRT20) between the two groups., 12 months|Differences in terms of plasmatic metabolites, Differences between the 2 intervention groups in terms of plasma metabolites., 12 months