LIver FRAilty Management IN Cirrhosis (LIFRAMIN)

NCT06573229 | Active Not Recruiting

• 1 other identifier: 6409 - LIFRAMIN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.
• nutritional counseling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
• nutritional counseling according to guidelines + placebo 20 g/day (4 scoops) for a total of 60 days (2 months).

Conditions

Sarcopenia; Cirrhosis, Liver; Malnutrition; Protein

Outcome Measures

Primary Outcomes (1)

• Improved functional capacity (Liver Frailty Index)

  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).

  12 months

Secondary Outcomes (3)

• Improved anthropometric and bioelectrical values and comparing the two

  12 months

• Improved QoL

  12 months

• Differences in terms of plasmatic metabolites

  12 months

Study Arms (2)

Aminolife Plus

EXPERIMENTAL

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.

Dietary Supplement: Aminolife Plus by Piemme Pharmatech, Italy

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Aminolife Plus by Piemme Pharmatech, Italy

Interventions

Aminolife Plus by Piemme Pharmatech, Italy DIETARY_SUPPLEMENT

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

Aminolife Plus; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Emanuele Rinninella

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis; Kwashiorkor

Condition Hierarchy (Ancestors)

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

Study Officials

• Emanuele Rinninella, PI

  Fondazione Policlinico Gemelli, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: August 2, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IT (1)