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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04096014
Status
Recruiting
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Conditions

  • Hepatic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 19, 2019
Start date
Sep 16, 2019
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Ensure Enlive
  • Placebo Comparator: Standard of Care

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Annette Bellar, BS
[email protected]
216-445-6268
Revathi Penumatsa
[email protected]
Srinivasan Dasarathy, MD (PRINCIPAL_INVESTIGATOR)

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Cleveland Clinic Foundation· Cleveland, OH

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