Overview
This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.
Description
Malnutrition and sarcopenia affect many patients awaiting liver transplantation and is associated with reduced quality of life and increased mortality. According to the current European Society for Clinical Nutrition and Metabolism (ESPEN) and European Association for the Study of the Liver (EASL) guidelines, a target of 1.2-1.5 g protein per kg body weight daily is recommended for patients with decompensated liver cirrhosis. While evidence supports that even protein distribution enhances muscle protein synthesis in healthy adults, specific protein timing recommendations are lacking for patients with end-stage liver disease.
Therefore, this randomized controlled trial aims to investigate the effects of a 12-week diet with even protein distribution plus exercise (Group A) versus skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C), primarily on nutritional status, body composition and functional status, and secondarily on anthropometric measurements, laboratory parameters, quality of life, disease severity, complications and mortality in liver transplant candidates. Moreover, late postoperative parameters, including length of hospital stay, length of intensive care unit stay, duration of mechanical ventilation, postoperative complications, hospital readmissions, reoperations and mortality will be examined for those who undergo transplantation.
Eligibility
Inclusion Criteria:
- End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture
- Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation
- No prior formal dietary advice
Exclusion Criteria:
- Age \< 18 years old
- Estimated waiting time for liver transplantation \< 3 months
- Estimated life expectancy \< 3 months
- Chronic kidney disease requiring protein restriction
- Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)
- Unstable or severe psychiatric disorder
- Pregnancy or lactation
- Inability to provide written informed consent
