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Diet plan may help fight muscle weakness in liver cirrhosis

NCT ID NCT07625085

Disease control Sponsor: University of Roma La Sapienza Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Liver cirrhosis often causes muscle weakness and frailty, even in stable patients. This study tested whether a personalized diet with extra calories and protein, along with nutrition counseling, could improve muscle strength and quality of life. About 70 adults with stable cirrhosis were randomly assigned to either the diet plan or usual care, and followed for 16 weeks.

What this could mean

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

Active substance
individualized diet plan (calorie and protein targets from regular foods, plus nutrition counseling)
What this could lead to
If it works, this could show that simple dietary changes can help people with liver cirrhosis maintain muscle strength and reduce frailty, improving daily life.
What could go wrong
This is a small, completed study with only 70 participants, so results may not apply to everyone. Diet plans can be hard to follow, and the effect on muscle strength may be modest.

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

70 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2025

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: ● Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, radiological, and/or histological evidence. * Outpatients who were clinically stable at the time of enrolment. * Child-Turcotte-Pugh (CTP) score ≤ 10. Exclusion Criteria: * Already receiving a structured nutrition intervention program or high-protein supplementation. * Presence of other severe co-morbidities that could confound outcomes. * History of chronic or recurrent hepatic encephalopathy. * Active alcohol consumption at the time of screening. * Expected poor compliance with study procedures. * Refusal to provide consent for participation. * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver

As listed by the trial registrant

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

Liver cirrhosis

Contacts and locations

Locations

  • Policlinico Umberto I

    Rome, Lazio, 00185, Italy

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