Comparing a special nutritional supplement to placebo for improving muscle mass in cirrhotic patients
LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
This study is testing if a special nutritional supplement can help people with liver cirrhosis and muscle loss gain muscle and improve their daily activities compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06573229 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Aminolife Plus, a special medical food, in enhancing muscle mass and functional ability in patients with liver cirrhosis and sarcopenia. Participants will be randomly assigned to receive either the supplement or a placebo alongside nutritional counseling for two months. The study will assess changes in weight, body mass index, lean mass, and quality of life, as well as differences in plasma metabolite production between the two groups. It is designed as a double-blind, randomized controlled trial to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with liver cirrhosis at any stage and a risk of sarcopenia as indicated by the SARC-F assessment.
Not a fit: Patients who do not show signs of sarcopenia or are unable to perform the required assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle mass and functional ability in patients with liver cirrhosis, enhancing their quality of life.
How similar studies have performed: While this approach is novel in the context of cirrhosis and sarcopenia, similar nutritional interventions have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome
- Emanuele Rinninella — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Emanuele Rinninella, PI — Fondazione Policlinico Gemelli, Rome
- Study coordinator: Emanuele Rinninella, MD
- Email: emanuele.rinninella@unicatt.it
- Phone: +390630154804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.