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

Who can join

Ages 18 to 75 · All sexes

Inclusion Criteria:

* \> 18 years of age
* cirrhosis diagnosed by clinical history and liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
* at least 1 hospitalization for documented HE within the last 12 months.
* abdominal CT scan anytime in the past

Exclusion Criteria:

* Patients with MELD score \> 35
* end stage organ failure (major dysfunction requiring organ support)
* kidney injury defined by a creatinine \> 2 mg/dl or rise in creatinine by 0.5 gm/dl from baseline that is unresponsive to withholding diuretics and intravenous albumin administration (1 gm/kg up to 100 gm/day)
* active malignancy
* uncontrolled diabetes mellitus with A1c\>9.5 (to avoid altered muscle protein metabolism
* medications (anabolic steroids, corticosteroids) that affect skeletal muscle mass
* recent gastrointestinal surgery within past 12 months
* ongoing infection (positive blood or other body fluid cultures)
* active gastrointestinal bleeding.

About the study

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.

What is being tested

• Ensure Enlive (dietary supplement)
• Standard Of Care (other)

Sponsor: The Cleveland Clinic · Participants: 40 · Started: Sep 16, 2019

Contact the study team

• Annette C Bellar · Phone: 2166365247

Official record on ClinicalTrials.gov — NCT04096014

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.