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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Muscle Atrophy

Treatments

Dietary Supplement: BCAA
Other: home-based graded exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT06088550
MD-173-2019

Details and patient eligibility

About

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).

Full 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

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 4 patient groups

Group-1
No Intervention group
Description:
received standard care
Group-2
Active Comparator group
Description:
received BCAA
Treatment:
Dietary Supplement: BCAA
Group-3
Active Comparator group
Description:
Recieved Exercice
Treatment:
Other: home-based graded exercise program
Group-4
Active Comparator group
Description:
Received a combined BCAA + Exercise
Treatment:
Other: home-based graded exercise program
Dietary Supplement: BCAA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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