Clinical trial NCT06088550: Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Atrophy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: a change from baseline of muscle quantity
timeFrame: 28 days
measure: a change from baseline of muscle strength
timeFrame: 28 days
measure: a change from baseline of muscle performance
timeFrame: 28 days
measure: a change from baseline of muscle quality
timeFrame: 28 days
Secondary outcomes:
measure: a change from the baseline of nutritional status
timeFrame: 28 days
measure: a change from the baseline of MELD score
timeFrame: 28 days
measure: a change from the baseline of ascites
timeFrame: 28 days
measure: a change from the baseline of hematological parameters
timeFrame: 28 days
measure: a change from the baseline of liver enzymes
timeFrame: 28 days
measure: a change from the baseline of BP
timeFrame: 28 days
measure: a change from the baseline edema
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Aliny School of Medicine
Study officials:
affiliation: Kasr Alainy School of Medicine
name: Elham Sobhy
role: PRINCIPAL_INVESTIGATOR
References: