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Active, Not Recruiting

NCT Number: NCT06573229

LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sarcopenia Atrophy Cirrhosis, Liver Digestive System Diseases Fibrosis Kwashiorkor Liver Cirrhosis Liver Diseases Malnutrition Malnutrition; Protein Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Severe Acute Malnutrition Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emanuele Rinninella

Rome, 00168, Italy

About this study

patients will be randomly allocated within the two groups:

  • nutritional counselling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
  • nutritional counselling according to guidelines + placebo 20 g/day (4 scoops)

The patients will be randomly allocated into two groups: the control group who will not take the treatment and the experimental group who will take the supplement. In detail, patients in the experimental group, in association with nutritional counselling, will take Aminolife plus 20 g/day (4 scoops) for two months (T0-T2).

Patients in the control group, in combination with nutritional counselling, will take placebo 20 g/day (4 scoops) for two months (T0-T2).

The division into the 2 groups will follow a block randomisation algorithm according to the Random Sorting procedure. The allocation sequence will be generated by means of the PASS2022 software.17 The allocation operator will be 'blinded' to the allocation group, just as the operator applying the treatment will not be involved in the evaluation of patients and results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients affected by Liver cirrhosis

  • at any stage of Child (A-B-C) with or without hepatocarcinoma
  • SARC-F suggestive of risk of sarcopenia
  • Age > 18 years
  • Ability to perform Liver Frailty Index test
  • Informed consent to participate in the study.

Exclusion criteria

  • SARC-F not suggestive of sarcopenia
  • inability to perform Liver Frailty Index test
  • absence of informed consent

Treatment and study plan

Aminolife Plus by Piemme Pharmatech, Italy

Dietary Supplement

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

Primary outcomes

  1. Improved functional capacity (Liver Frailty Index)

    Time frame: 12 months

    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).

Secondary outcomes

  1. Improved anthropometric and bioelectrical values and comparing the two

    Time frame: 12 months

    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);

  2. Improved QoL

    Time frame: 12 months

    Differences in quality of life indices (QLQ-C30, QLQ-CR29, QLQ-CAX24, QLQ-PRT20) between the two groups.

  3. Differences in terms of plasmatic metabolites

    Time frame: 12 months

    Differences between the 2 intervention groups in terms of plasma metabolites.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: LIFRAMIN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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