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

Effect of Branched-chain Amino Acid Supplementation and Exercise on Quadriceps Muscle Quantity and Quality in Patients With Cirrhosis as Assessed by Ultrasonography

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).

Study Overview

• Status: Completed
• Conditions: Muscle Atrophy
• Intervention / Treatment: Dietary supplement: BCAA; Other: home-based graded exercise program

Detailed Description

This is an open, 4-arm parallel, randomized controlled trial conducted on cirrhotic patients

All eligible patients received instructions of standard care that includes standard diet and non-exercise activity thermogenesis (NEAT), then the patients were randomly assigned in an allocation ratio of approximately 1:1:1:1; group 1= control received the standard care only, and three intervention groups; group 2 received added 10 gm/day branched-chain amino acid (BCAA) (manufactured by Dulex lab company). Group 3 received added home-based exercise comprising both aerobic and resistance exercises, and finally, group 4 received added both BCAA and home-based exercise.

All patients were subjected to the following at the baseline and after 28 days:

1. thorough medical history
2. Complete clinical examination including BP, middle upper arm circumference (MUC), and body mass index (BMI) using the dry weight.
3. The nutritional status assessment using the 7-point Subjective Global Assessment (SGA) score,
4. Assessment of their physical fitness using the short physical performance battery test (SPPB) score.
5. Assessment of muscle strength using handgrip strength using a digital dynamometer (Model: 12-0286).
6. Routine labs including complete blood count (CBC), liver function, kidney function, and electrolytes, FBG
7. Calculation of Child-Pugh & MELD scores.
8. Ultrasound assessment of quadriceps muscle thickness and echogenicity

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12346
    • Kasr Aliny School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Cirrhotic patients with moderate and marked liver impairment

Exclusion Criteria:

• cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group-1; received standard care
Active Comparator: Group-2; received BCAA	Dietary supplement: BCAA; a branched-chain amino acid (BCAA) formula: taken by oral route in the form of 2 scoops of Protofit BCAA daily on 200 cc water, (manufactured by Dulex lab company). Each scoop contains 5 gm BCAA (2.5 gm leucine, 1.25 gm isoleucine & 1.25 gm valine).
Active Comparator: Group-3; Recieved Exercice	Other: home-based graded exercise program; home-based graded exercise program comprises both aerobic and resistance exercise. The exercise was done by the patients themselves aided by a physiotherapist, a nurse or patients' relatives
Active Comparator: Group-4; Received a combined BCAA + Exercise	Dietary supplement: BCAA; a branched-chain amino acid (BCAA) formula: taken by oral route in the form of 2 scoops of Protofit BCAA daily on 200 cc water, (manufactured by Dulex lab company). Each scoop contains 5 gm BCAA (2.5 gm leucine, 1.25 gm isoleucine & 1.25 gm valine).; Other: home-based graded exercise program; home-based graded exercise program comprises both aerobic and resistance exercise. The exercise was done by the patients themselves aided by a physiotherapist, a nurse or patients' relatives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a change from baseline of muscle quantity	assessed by ultrasound quadriceps muscle thickness	28 days
a change from baseline of muscle strength	assessed by handgrip strength	28 days
a change from baseline of muscle performance	assessed by the short physical performance battery test (SPPB)	28 days
a change from baseline of muscle quality	assessed by ultrasound quadriceps muscle echo intensity	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a change from the baseline of nutritional status	assessed by 7-point Subjective Global Assessment (SGA) score	28 days
a change from the baseline of MELD score	assessed by calculating MELD score at baseline and after 28 days	28 days
a change from the baseline of ascites	assessed by subjective clinical grading	28 days
a change from the baseline of hematological parameters	assessed by CBC	28 days
a change from the baseline of BP	assessed by measuring BP	28 days
a change from the baseline edema	assessed by clinical grading	28 days
a change from the baseline of liver enzymes	assessed by laboratory assessment of liver enzymes	28 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Elham Sobhy, Kasr Alainy School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy
• Other Study ID Numbers: MD-173-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No