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

NCT04096014 | Recruiting

• 1 other identifier: 18-749
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Change in number of readmissions

  Day 0 & Day 180

Study Arms (2)

Ensure Enlive

ACTIVE COMPARATOR

Dietary Supplement: Ensure Enlive; Other: Standard Of Care

Standard of Care

PLACEBO COMPARATOR

Other: Standard Of Care

Interventions

Ensure Enlive DIETARY_SUPPLEMENT

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

Ensure Enlive

Standard Of Care OTHER

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

Ensure Enlive; Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Annette C Bellar

CONTACT

2166365247; bellara@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 19, 2019
• Study Start: September 16, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)