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Can a simple supplement reverse muscle wasting in liver disease?

NCT ID NCT05166499

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a special mix of amino acids with HMB can help reverse muscle loss in people with cirrhosis. Muscle loss is common in cirrhosis and can make patients weaker and increase risks before and after liver transplant. The trial will give participants either the HMB-enriched supplement or a balanced amino acid mix for 3 months and measure changes in muscle protein synthesis.

What this could mean

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

Active substance
Hydroxy Methyl Butyrate (HMB) and essential amino acids
What this could lead to
If it works, this could point toward a treatment to reverse muscle loss in cirrhosis, potentially improving quality of life and outcomes before and after liver transplant.
What could go wrong
This is a small, early-phase study with only 24 participants, so results may not apply to everyone. The supplement may not significantly improve muscle mass or function.

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 24 people

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

Started

Nov 2021

Expected to finish

Dec 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

21 to 65 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: * Diagnosis of cirrhosis of the liver * Child-Pugh score of 5-8 Exclusion Criteria: * Recent gastrointestinal bleeding (\<3m) * Active infection * Overt encephalopathy * Renal failure on dialysis * Pedal edema * Uncontrolled diabetes (HbA1C \> 7.9mg/dL) * Advanced cardiac, lung, kidney disease * Metastatic cancer * Medications that alter muscle protein metabolism * Pregnancy * Recent bowel resection or gastric bypass surgery, * INR \>1.7, platelets \<60,000/ml, serum creatinine \>2mg/dL * Medications that interfere with blood clotting

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    RECRUITING

    Cleveland, Ohio, 44195, United States

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