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NCT Number: NCT06088550

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

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).

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Key information

Conditions

Muscle Atrophy Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Aliny School of Medicine

Cairo, 12346, Egypt

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCAA

Dietary Supplement

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).

home-based graded exercise program

Other

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

Primary outcomes

  1. a change from baseline of muscle quantity

    Time frame: 28 days

    assessed by ultrasound quadriceps muscle thickness

  2. a change from baseline of muscle strength

    Time frame: 28 days

    assessed by handgrip strength

  3. a change from baseline of muscle performance

    Time frame: 28 days

    assessed by the short physical performance battery test (SPPB)

  4. a change from baseline of muscle quality

    Time frame: 28 days

    assessed by ultrasound quadriceps muscle echo intensity

Secondary outcomes

  1. a change from the baseline of nutritional status

    Time frame: 28 days

    assessed by 7-point Subjective Global Assessment (SGA) score

  2. a change from the baseline of MELD score

    Time frame: 28 days

    assessed by calculating MELD score at baseline and after 28 days

  3. a change from the baseline of ascites

    Time frame: 28 days

    assessed by subjective clinical grading

  4. a change from the baseline of hematological parameters

    Time frame: 28 days

    assessed by CBC

  5. a change from the baseline of liver enzymes

    Time frame: 28 days

    assessed by laboratory assessment of liver enzymes

  6. a change from the baseline of BP

    Time frame: 28 days

    assessed by measuring BP

  7. a change from the baseline edema

    Time frame: 28 days

    assessed by clinical grading

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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