Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04096014
NA

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2019-09-16

Completion Date

2026-10-30

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States