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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 90 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare Fractional Synthesis Rate

Trial Design

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

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,021 Previous Clinical Trials
1,365,698 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: Leucine enriched essential amino acid, Balanced amino acid supplement
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

Frequently Asked Questions

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

Could I potentially be included in this clinical examination?

"This clinical study is accepting up to 32 people with fibrosis who are between 18 and 70 years old."

Answered by AI

What is the sample population of this research endeavor?

"Indeed, clinicaltrials.gov points to this trial as actively searching for participants who can be found at 1 medical centre. The study was first posted on August 5th 2013 and recently updated on March 7th 2022 with the aim of recruiting 32 patients in total."

Answered by AI

Is geriatric age eligibility taken into account for this research?

"The age range for this trial is limited to 18-70. There are 76 clinical studies conducted on people younger than 18 and 429 trials which focus on elderly individuals greater than 65 years of age."

Answered by AI

Are there any vacancies available for prospective participants in this experiment?

"Correct. Per the clinicaltrials.gov website, this medical investigation is in progress and accepting participants; it was launched on August 5th 2013, with updates occurring most recently on March 7th 2022. 32 patients must be recruited from a single site for proper completion of the study's protocol."

Answered by AI
~2 spots leftby Dec 2024