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Amino Acid Supplement

Leucine Enriched Amino Acids for Liver Cirrhosis

N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cirrhosis diagnosed by liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis
Child's Pugh score 5-9 (inclusive)
Must not have
Sepsis, encephalopathy
Hepatocellular carcinoma outside of Milan criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether leucine will help increase muscle mass in people with cirrhosis, by looking at the response to leucine in cirrhotic patients compared to a control group. They will measure this by looking at the rate of protein synthesis in muscle, and how this changes in response to leucine.

Who is the study for?
This trial is for individuals with liver cirrhosis, confirmed by biopsy or other methods, who have a moderate level of disease severity (Child's Pugh score 5-9) and have not consumed alcohol or recreational drugs for at least six months. People with severe cirrhosis, swelling in the legs, other serious illnesses, diabetes, recent bleeding from the gut, brain issues due to liver disease, kidney failure or certain cancers can't join.
What is being tested?
The study is testing whether a special mix of amino acids including leucine (EAA/LEU), which may help build muscle protein and mass, works better than a balanced amino acid supplement (BAA) that doesn't stimulate muscle growth. The effects will be measured over three months using blood markers and muscle biopsies.
What are the potential side effects?
Potential side effects are not detailed but could include discomfort at the biopsy site and possible reactions to supplements such as gastrointestinal upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with cirrhosis through a biopsy or tests.
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My liver function score is between 5 to 9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have sepsis or brain dysfunction.
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My liver cancer does not meet the Milan criteria.
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I am currently experiencing bleeding in my stomach or intestines.
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I have swelling in my feet above the ankles.
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I have kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare Fractional Synthesis Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Balanced amino acid supplementActive Control1 Intervention
Patients with cirrhosis that are given a balanced amino acid (BAA) supplement.
Group II: Leucine enriched essential amino acidActive Control1 Intervention
Patients with cirrhosis that are given a leucine enriched essential amino acid (EEA/LEU) supplement.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,728 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
1,600 Patients Enrolled for Liver Cirrhosis

Media Library

Leucine enriched essential amino acid (EEA/LEU) (Amino Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03208868 — N/A
Liver Cirrhosis Research Study Groups: Balanced amino acid supplement, Leucine enriched essential amino acid
Liver Cirrhosis Clinical Trial 2023: Leucine enriched essential amino acid (EEA/LEU) Highlights & Side Effects. Trial Name: NCT03208868 — N/A
Leucine enriched essential amino acid (EEA/LEU) (Amino Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03208868 — N/A
~0 spots leftby Dec 2024
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