LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

NCT ID: NCT06573229

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-02
• Study Completion Date: 2025-10-30

Brief 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.

Detailed Description

patients will be randomly allocated within the two groups:

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

2. 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.

Conditions

Sarcopenia; Cirrhosis, Liver; Malnutrition; Protein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aminolife Plus

Food supplement based on milk protein serum (Isolac Instant), acetyl-carnitine, hydroxy-methyl-butyrate, arginine, inositol, coenzyme Q10 and extracts of perilla, maca and mallow. Perilla supports the body's natural defences, maca has a tonic and metabolic support action and mallow has an emollient and soothing action (digestive system, urinary tract). Calcium, vitamin D and vitamin K2 complete the formulation. Calcium contributes to energy metabolism and is necessary for maintaining normal bones. Vitamin D modulates the immune system and contributes to regular muscle function. Vitamin aK2 contributes to proper blood clotting and maintenance of normal bones.

Group Type: EXPERIMENTAL

Aminolife Plus by Piemme Pharmatech, Italy

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

It is an inactive substance or treatment that has no therapeutic effect and is often used as a control in clinical trials.

Group Type: PLACEBO_COMPARATOR

Aminolife Plus by Piemme Pharmatech, Italy

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Aminolife Plus by Piemme Pharmatech, Italy

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Rinninella Emanuele, MD, PhD

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emanuele Rinninella, PI

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli, Rome

Locations

Emanuele Rinninella

Rome, , Italy

Countries

Italy

Other Identifiers

6409 - LIFRAMIN

Identifier Type: -

Identifier Source: org_study_id