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

Muscle Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06088550
• Other study ID #: MD-173-2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Atrophy
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Aliny School of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change from baseline of muscle quantity	assessed by ultrasound quadriceps muscle thickness	28 days
Primary	a change from baseline of muscle strength	assessed by handgrip strength	28 days
Primary	a change from baseline of muscle performance	assessed by the short physical performance battery test (SPPB)	28 days
Primary	a change from baseline of muscle quality	assessed by ultrasound quadriceps muscle echo intensity	28 days
Secondary	a change from the baseline of nutritional status	assessed by 7-point Subjective Global Assessment (SGA) score	28 days
Secondary	a change from the baseline of MELD score	assessed by calculating MELD score at baseline and after 28 days	28 days
Secondary	a change from the baseline of ascites	assessed by subjective clinical grading	28 days
Secondary	a change from the baseline of hematological parameters	assessed by CBC	28 days
Secondary	a change from the baseline of liver enzymes	assessed by laboratory assessment of liver enzymes	28 days
Secondary	a change from the baseline of BP	assessed by measuring BP	28 days
Secondary	a change from the baseline edema	assessed by clinical grading	28 days