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

NCT ID: NCT04096014

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2026-10-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ensure Enlive

Group Type: ACTIVE_COMPARATOR

Ensure Enlive

Intervention Type: DIETARY_SUPPLEMENT

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

Standard Of Care

Intervention Type: OTHER

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

Standard of Care

Group Type: PLACEBO_COMPARATOR

Standard Of Care

Intervention Type: OTHER

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

Interventions

Ensure Enlive

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

Intervention Type: DIETARY_SUPPLEMENT

Standard Of Care

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Srinivasan Dasarathy

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Annette C Bellar

Role: CONTACT

bellara@ccf.org

2166365247 ext. 2166365247

Facility Contacts

Annette Bellar, BS

Role: primary

bellara@ccf.org

216-445-6268

Revathi Penumatsa

Role: backup

penumar@ccf.org

Other Identifiers

18-749

Identifier Type: -

Identifier Source: org_study_id