Recruiting

Protein Supplement

Sponsor:

The Cleveland Clinic

Code:

NCT04096014

Conditions

Hepatic Encephalopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ensure Enlive

Standard Of Care

Study Details

Brief 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

Study ID

NCT04096014

Start date

Sep 16, 2019

Status verified date

Nov, 2025

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Ensure Enlive

placebo comparator: Standard of Care

Interventions

Ensure Enlive

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

Standard Of Care

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

Primary outcome measure

  • Determine if decreasing nocturnal fasting by protein supplements will change readmission rates. [ Time Frame: Day 0 & Day 180 ]

Central Contacts and Locations

Central contacts

Annette C Bellar

2166365247bellara@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Annette Bellar, BS

216-445-6268bellara@ccf.org

Revathi Penumatsa

penumar@ccf.org

Principal Investigator:

Srinivasan Dasarathy, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-11-25.