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

NCT04096014 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2026-06-30
Completion
2026-10-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096014 on ClinicalTrials.gov