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Amino Acid Supplement

Leucine Enriched Essential Amino Acid (EEA/LEU) for Liver Cirrhosis

Cleveland Clinic Foundation, Cleveland, OH

Leucine enriched essential amino acid (EEA/LEU) +1 moreN/ARecruitingResearch 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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline to 90 days

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Liver Cirrhosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You haven't used alcohol or recreational drugs for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 90 days

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

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: 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,000 Previous Clinical Trials

1,350,944 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

Recent research and studies

clinicaltrials.govStudy

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

Srinivasan Dasarathy 2013. "Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03208868.

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