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LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

Study acronym: LIFRAMIN
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 2 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2025 to Oct 30, 2025
    • Site details revised
    v6
  3. Notable Primary completion date: Dec 31, 2024 to Jun 30, 2025
    • Study completion date: Feb 28, 2025 to Jun 30, 2025
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Study description expanded, about 163 words
    • Site details revised
    v3
  6. Minor Secondary endpoints revised (3)
    • Site details revised
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06573229
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)
Sarcopenia, Cirrhosis, Liver, Malnutrition; Protein
Related terms Kwashiorkor, Liver Cirrhosis, Sarcopenia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov