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Amino Acid Supplement

HMB + 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
Diagnosis of cirrhosis of the liver
Child-Pugh score of 5-8
Must not have
Metastatic cancer
Overt encephalopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 90
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether or not leucine can help to improve the muscle mass of cirrhotic patients by stimulating protein synthesis.

Who is the study for?
This trial is for individuals with a moderate level of liver cirrhosis, as indicated by a Child-Pugh score of 5-8. Participants must not have had recent severe complications like gastrointestinal bleeding or infections, and should not be on dialysis or have uncontrolled diabetes among other exclusions.
What is being tested?
The study is testing whether HMB enriched amino acids can reverse muscle loss in people with cirrhosis. It compares this intervention to a balanced amino acid mixture that doesn't stimulate protein synthesis, over an acute phase and then long-term for three months.
What are the potential side effects?
While the trial's description does not specify side effects, potential risks may include discomfort at biopsy sites, allergic reactions to supplements, and imbalances in blood chemistry due to changes in protein metabolism.

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 of the liver.
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My liver function is moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to other parts of my body.
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I have been diagnosed with severe brain function problems.
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I am on dialysis for kidney failure.
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I do not have severe heart, lung, or kidney disease.
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I currently have an infection.
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I am not taking any medications that affect blood clotting.
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I have swelling in my feet.
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I recently had surgery on my intestines or stomach.
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I have not had any bleeding in my stomach or intestines in the last 3 months.
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I am not taking any medications that affect muscle growth or breakdown.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fractional Synthesis Rate of Skeletal Muscle

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Balanced Amino Acid MixtureExperimental Treatment1 Intervention
Group II: Hydroxy Methyl ButyrateActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,736 Total Patients Enrolled
8 Trials studying Liver Cirrhosis
1,608 Patients Enrolled for Liver Cirrhosis

Media Library

Hydroxy Methyl Butyrate (Amino Acid Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05166499 — N/A
Liver Cirrhosis Research Study Groups: Hydroxy Methyl Butyrate, Balanced Amino Acid Mixture
Liver Cirrhosis Clinical Trial 2023: Hydroxy Methyl Butyrate Highlights & Side Effects. Trial Name: NCT05166499 — N/A
Hydroxy Methyl Butyrate (Amino Acid Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166499 — N/A
~6 spots leftby Dec 2025
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