NCT04096014

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ensure Enlive	The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
OTHER	Standard Of Care	The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Timeline

• Start date: 2019-09-16
• Primary completion: 2026-06-30
• Completion: 2026-10-30
• First posted: 2019-09-19
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States