MedTrace Logo

LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

NCT06573229 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

  • Sarcopenia
  • Cirrhosis, Liver
  • Malnutrition; Protein

Interventions

DIETARY_SUPPLEMENT

Aminolife Plus by Piemme Pharmatech, Italy

A nutritional supplement containing whey protein, vitamin D, carnitine, HMB, perilla, arginine, coenzyme Q10, inositol)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Emanuele Rinninella, PI · Fondazione Policlinico Gemelli, Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06573229 on ClinicalTrials.gov