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NCT Number: NCT04096014

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Annette Bellar, BS

CONTACT

[email protected]

216-445-6268

Revathi Penumatsa

CONTACT

[email protected]

Srinivasan Dasarathy, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ensure Enlive

Dietary Supplement

The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.

Standard of care

Other

The subjects in the Standard of care group will continue to receive the standard clinical therapy.

Primary outcomes

  1. Determine if decreasing nocturnal fasting by protein supplements will change readmission rates.

    Time frame: Day 0 & Day 180

    Change in number of readmissions

Study contacts

Contact information is provided by the study sponsor or research team.

Annette C Bellar

CONTACT

[email protected]

2166365247 ext. 2166365247

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2019
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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