Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy

What this Trial Is About

This research is focused on patients with hepatic encephalopathy caused by end-stage liver disease, a condition with high rates of hospital readmission. The study aims to evaluate whether nutritional intervention using protein supplements can reduce recurrent episodes of encephalopathy and subsequent hospital stays. The study is a randomized trial led by The Cleveland Clinic, addressing the problem of hyperammonemia and muscle breakdown in these patients. Participants are divided into two groups: one receives two daily doses of a protein supplement called Ensure Enlive for six months, while the other group continues with standard clinical care. The intervention targets the reduction of muscle protein breakdown by providing protein supplements late in the evening and early in the morning. The study period for this intervention lasts for 180 days. During the trial, researchers will monitor hospital readmission rates at the start and end of the 180-day period to assess the impact of the supplements. Participants will undergo assessments including abdominal CT scans and clinical evaluations for liver disease severity and muscle mass. The main outcome measure is to determine if reducing overnight fasting with protein supplementation decreases readmissions. The study includes safety monitoring and runs until October 2026.

Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy