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Can a protein shake keep liver patients out of the hospital?

NCT ID NCT04096014

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking a protein supplement (Ensure Enlive) in the late evening and early morning can reduce hospital readmissions for people with hepatic encephalopathy, a brain condition caused by liver disease. The trial enrolls 40 adults with cirrhosis who have been hospitalized for this condition in the past year. Participants either receive the supplement for 180 days or continue standard care, and researchers track how many are readmitted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ensure Enlive (protein supplement)
What this could lead to
If it works, this could offer a simple dietary way to reduce hospital readmissions for people with liver-related brain fog.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to everyone. The supplement may not lower readmission rates as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic encephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

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