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

NCT06088550 | Completed

• 1 other identifier: MD-173-2019
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscle Atrophy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• a change from the baseline of nutritional status

  28 days

• a change from the baseline of MELD score

  28 days

• a change from the baseline of ascites

  28 days

• a change from the baseline of hematological parameters

  28 days

• a change from the baseline of liver enzymes

  28 days

Study Arms (4)

Group-1

NO INTERVENTION

received standard care

Group-2

ACTIVE COMPARATOR

received BCAA

Dietary Supplement: BCAA

Group-3

ACTIVE COMPARATOR

Recieved Exercice

Other: home-based graded exercise program

Group-4

ACTIVE COMPARATOR

Received a combined BCAA + Exercise

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

Interventions

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).

Group-2; Group-4

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

Group-3; Group-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhotic patients with moderate and marked liver impairment

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Aliny School of Medicine

Cairo, 12346, Egypt

Location

Related Publications (1)

• Sobhy E, Kamal MM, Saad Y, Saleh DA, Elgohary R, Hassan MS. Effect of branched-chain amino acid supplementation and exercise on quadriceps muscle quantity and quality in patients with cirrhosis as assessed by ultrasonography: A randomized controlled trial. Clin Nutr ESPEN. 2024 Jun;61:108-118. doi: 10.1016/j.clnesp.2024.03.011. Epub 2024 Mar 15.

  PMID: 38777422 DERIVED

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

• Elham Sobhy

  Kasr Alainy School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: October 18, 2023
• Study Start: November 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)