Clinical trial NCT06573229: LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
Official title: LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Cirrhosis, Liver
Malnutrition; Protein
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improved functional capacity (Liver Frailty Index)
timeFrame: 12 months
Secondary outcomes:
measure: Improved anthropometric and bioelectrical values and comparing the two
timeFrame: 12 months
measure: Improved QoL
timeFrame: 12 months
measure: Differences in terms of plasmatic metabolites
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Emanuele Rinninella
Study officials:
affiliation: Fondazione Policlinico Gemelli, Rome
name: Emanuele Rinninella, PI
role: PRINCIPAL_INVESTIGATOR
References: