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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group-1

received standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Group-2

received BCAA

Group Type ACTIVE_COMPARATOR

BCAA

Intervention Type 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-3

Recieved Exercice

Group Type ACTIVE_COMPARATOR

home-based graded exercise program

Intervention Type 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-4

Received a combined BCAA + Exercise

Group Type ACTIVE_COMPARATOR

BCAA

Intervention Type 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

Intervention Type 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

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No