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Leucine Enriched Essential Amino Acid Mixture for Muscle Loss in Cirrhosis

This study is looking at ways to reverse muscle loss (sarcopenia) in people with cirrhosis, a common and serious complication. Researchers are testing two dietary supplements: a Leucine enriched essential amino acid mixture (EEA/LEU) and a balanced amino acid supplement (BAA). They want to see if either supplement can improve muscle protein production by affecting a process called mTOR signaling. You may be able to join if you are 18-70 years old, have cirrhosis, and meet other specific health criteria. The study aims to enroll 32 participants and will compare muscle protein production over 90 days to see which supplement is more effective. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 32 participants. You would be randomly assigned to receive either the Leucine enriched essential amino acid mixture or the balanced amino acid supplement.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Fractional Synthesis Rate, is measured from baseline to 90 days.

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NCT03208868

Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Recruiting
NAAges 18–70InterventionalPrevention
The Cleveland Clinic
~32 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Leucine enriched essential amino acid (EEA/LEU)Balanced amino acid supplement (BAA)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare Fractional Synthesis Rate
Measured over Baseline to 90 days

Conditions

Cirrhosis, Liver

Explore related trials

Cirrhosis

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Annette Bellar, BS
[email protected]
216-636-5247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cirrhotic patients:
Cirrhosis diagnosed by liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis.
Abstinence from alcohol and/or other recreational drugs for at least 6 months
Child's Pugh score 5-9 (inclusive).
Cirrhotic patients:
Child's score \>9
Pedal edema above the ankle
Presence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass.
Diabetes mellitus
Active gastrointestinal bleeding
Sepsis, encephalopathy
Renal failure
Hepatocellular carcinoma outside of Milan criteria
Unwilling to sign informed consent or follow research procedures

What this trial measures

  • Compare Fractional Synthesis RateBaseline to 90 days

    To test whether fractional synthesis of skeletal muscle proteins changes from baseline to 90 days with the administration of BAA or EAA/LEU. Fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of the L- \[ring D5\] phenylalanine into the proteins and the free tissue phenylalanine enrichments using precursor product model: FSR= (∆Ep/t)/(∆Ec) x60x100 and expressed as %/hour. ΔEp is the increment in myofibrillar protein-bound L- \[ring D5\] phenylalanine enrichment, t is the time between the muscle biopsies. ∆Ec is the L- \[ring D5\] phenylalanine enrichments in the free intracellular pool in the muscle biopsies.