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RecruitingNCT04096014Updated Sep 25, 2026

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

An interventional study of Ensure Enlive and Standard Of Care in Hepatic Encephalopathy, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic Encephalopathy
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Ensure Enlive

    Dietary Supplement: Ensure Enlive · Other: Standard Of Care

  • Placebo comparator
    Standard of Care

    Other: Standard Of Care

Interventions

  • Dietary supplementEnsure Enlive

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

  • OtherStandard Of Care

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

05

What researchers measure

Primary outcomes

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

    Change in number of readmissions

    Time frame: Day 0 & Day 180

06

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
    • Annette Bellar, BS · Contact · bellara@ccf.org · 216-445-6268
    • Revathi Penumatsa · Contact · penumar@ccf.org
    • Srinivasan Dasarathy, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04096014
Lead sponsor
The Cleveland Clinic
Responsible party
Srinivasan Dasarathy (Staff Physician, The Cleveland Clinic) — Principal investigator
First posted
Sep 19, 2019
Start date
Sep 16, 2019
Primary completion
Jun 30, 2027 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Annette C Bellar
Contact
bellara@ccf.org
2166365247 ext. 2166365247

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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