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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 90
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fractional Synthesis Rate of Skeletal Muscle

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
1,021 Previous Clinical Trials
1,365,706 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the requirements to participate in this experiment?

"This experiment is seeking 24 individuals with liver cirrhosis between the ages of 21 and 65; they must also have a Child-Pugh score ranging from 5 to 8."

Answered by AI

Are there any current open recruitment initiatives related to this experiment?

"Reportedly, this investigation is still enrolling participants. The protocol was first uploaded to clinicaltrials.gov on November 30th 2021 and the data were updated as recently as October 19th 2022."

Answered by AI

Does this research endeavor allow persons under 35 years old to participate?

"Patients that are eligible to participate in this medical study must be between 21 and 65 years of age. For those who fall outside of this range, 76 trials exist for people under 18 while 429 studies cover individuals above the retirement-age threshold."

Answered by AI

How many participants have successfully enrolled in this research project?

"Affirmative. Current records hosted on clinicaltrials.gov suggest that this medical trial, which was launched on November 30th 2021, is currently recruiting patients. A total of 24 participants are needed for the study taking place at a single location."

Answered by AI
~10 spots leftby Dec 2025