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NCT06088550

Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis

Completed NA Last updated 19 March 2024
What this trial tests

NA trial testing BCAA in Muscle Atrophy in 220 participants. Completed in 30 December 2022.

Timeline
1 November 2020
Primary endpoint
30 June 2022
30 December 2022

Quick facts

Lead sponsorCairo University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment220
Start date1 November 2020
Primary completion30 June 2022
Estimated completion30 December 2022
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

18 and older, any sex, with Muscle Atrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Ultrasound can be used to monitor muscle mass during interventional approaches in patients with liver cirrhosis. The aim: To investigate the effect of branched-chain amino acid (BCAA) supplementation and/or muscle exercise on ultrasound-measured quadriceps muscle thickness and echo intensity, as well as on muscle strength, performance, and nutritional assessment in patients with cirrhosis. Patients \& Methods: This is a randomized controlled study that included 220 liver cirrhosis patients with Child-Pugh B \& C classes. They were randomized into a control group comprising 55 patients who received only the standard care, and interventional groups comprising 165 patients equally distributed into three groups, they received in addition to standard care, BCAA, programmed exercise, or BCAA and programmed exercise respectively. At baseline and after 28 days, all participants were subjected to ultrasound-measured quadriceps muscle thickness and echo intensity, in addition to handgrip strength, short physical performance battery (SPPB), anthropometric measures, hematological and biochemical assessment, MELD score measurement, nutritional assessment using 7- subjective global assessment score (SGA).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of branched-chain amino acid supplementation and exercise on quadriceps muscle quantity and quality in patients with cirrhosis as assessed by ultrasonography: A randomized controlled trial.
    Sobhy E, Kamal MM, Saad Y, Saleh DA, et al · · 2024 · cited 8× · PMID 38777422 · DOI 10.1016/j.clnesp.2024.03.011

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Data sources for this page

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