Muscle AtrophyNCT06088550
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
A study testing BCAA and home-based graded exercise program in people with Muscle Atrophy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Atrophy
- What is being tested?
- BCAA and home-based graded exercise program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients with moderate and marked liver impairment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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:
- 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
- Conditions
- Muscle Atrophy
- Being tested
- BCAA, home-based graded exercise program
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary 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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | No intervention | received standard care |
| Group-2 | Active comparator | received BCAA Receives: Dietary Supplement: BCAA |
| Group-3 | Active comparator | Recieved Exercice Receives: Other: home-based graded exercise program |
| Group-4 | Active comparator | Received a combined BCAA + Exercise Receives: Dietary Supplement: BCAA; Other: home-based graded exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
a change from baseline of muscle quantity
assessed by ultrasound quadriceps muscle thickness
Measured: 28 days
a change from baseline of muscle strength
assessed by handgrip strength
Measured: 28 days
a change from baseline of muscle performance
assessed by the short physical performance battery test (SPPB)
Measured: 28 days
a change from baseline of muscle quality
assessed by ultrasound quadriceps muscle echo intensity
Measured: 28 days
Secondary outcomes (7)
a change from the baseline of nutritional status
assessed by 7-point Subjective Global Assessment (SGA) score
Measured: 28 days
a change from the baseline of MELD score
assessed by calculating MELD score at baseline and after 28 days
Measured: 28 days
a change from the baseline of ascites
assessed by subjective clinical grading
Measured: 28 days
a change from the baseline of hematological parameters
assessed by CBC
Measured: 28 days
a change from the baseline of liver enzymes
assessed by laboratory assessment of liver enzymes
Measured: 28 days
a change from the baseline of BP
assessed by measuring BP
Measured: 28 days
a change from the baseline edema
assessed by clinical grading
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Nov 2020
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmia Elgohary, Cairo University
- Investigators
- Elham Sobhy, Principal investigator, Kasr Alainy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088550
- Sponsor's protocol ID
- MD-173-2019
- Status last verified
- Mar 2024
- First submitted
- 26 Aug 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38777422
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06088550
- Acronym / sponsor ID
- MD-173-2019
- Conditions
- Muscle Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group-1 | No intervention | –received standard care |
| Group-2 | Active comparator | Dietary Supplement: BCAAreceived BCAA |
| Group-3 | Active comparator | Other: home-based graded exercise programRecieved Exercice |
| Group-4 | Active comparator | Dietary Supplement: BCAA, Other: home-based graded exercise programReceived a combined BCAA + Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients with moderate and marked liver impairment
Key exclusion criteria (1 listed)
- cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAAa 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). | Dietary supplement | Group-2, Group-4 |
| home-based graded exercise programhome-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 | Other | Group-3, Group-4 |
Primary outcome
a change from baseline of muscle quantity
Time frame: 28 days
assessed by ultrasound quadriceps muscle thickness
a change from baseline of muscle strength
Time frame: 28 days
assessed by handgrip strength
a change from baseline of muscle performance
Time frame: 28 days
assessed by the short physical performance battery test (SPPB)
a change from baseline of muscle quality
Time frame: 28 days
assessed by ultrasound quadriceps muscle echo intensity
7 secondary outcomes
a change from the baseline of nutritional status
Time frame: 28 days
a change from the baseline of MELD score
Time frame: 28 days
a change from the baseline of ascites
Time frame: 28 days
a change from the baseline of hematological parameters
Time frame: 28 days
a change from the baseline of liver enzymes
Time frame: 28 days
a change from the baseline of BP
Time frame: 28 days
a change from the baseline edema
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 38777422Sobhy 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.
- Individual participant dataSharing planned: No
Related trials for Muscle Atrophy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham Sobhy principal investigator
Kasr Alainy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA and home-based graded exercise program in people with Muscle Atrophy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a change from baseline of muscle quantity (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.