Critical IllnessSOFANCT06167772
Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, SOFA Score in Critical Illness
A study testing BCAA, Standard nutrition and Standard physiotherapy in people with Critical Illness and Muscle Wasting, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Illness, Muscle Wasting
- What is being tested?
- BCAA, Standard nutrition and Standard physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesIndonesia
- Study dates
- 14 Dec 2023to 10 May 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new admission to intensive care unit (ICU) in first 24 hours
- aged 18-65 years
- SOFA score >= 4
Who cannot join
- pregnant
- ultrasound examination cannot be performed under these circumstances: deformities, open wounded, prosthetics on right leg, amputated above right patella
- body mass index <16 kg/m2
- chronic kidney disease stage 3-5
- diabetes mellitus uncontrolled blood glucose (BG) (BG >200 mg/dL)
- neuromuscular diseases with musculus quadriceps femoris dextra paralysis
- autoimmune diseases
- referral from another ICU
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Universitas Indonesia Hospital
Depok, West Java
Dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Effects of Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, and Sequential Organ Failure Assessment Score in Critically Ill Patients
The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study.
Read the detailed description
The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study. Both groups will be given standard nutrition with target energy of 20 kcal/kg bodyweight(BW)/day and ratio of nitrogen:non-protein calorie 1:70 and neuromuscular electrical stimulation 30 minutes per day.
- Conditions
- Critical Illness, Muscle Wasting
- Being tested
- BCAA, Standard nutrition, Standard physiotherapy
- Keywords
- Leucine, Branched-chain amino acid, Muscle wasting, Critically-ill patients, Muscle thickness, Interleukin-6, Sequential organ failure assessment score
- Medical subject headings
- Critical Illness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary supplement
branched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag.
frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral \& parenteral.
duration: 10 days
Standard nutritionOther
Also called High protein oral nutritional supplementation
Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70
Standard physiotherapyOther
Also called Neuromuscular electrical stimulation
A symmetric biphasic rectangular pulse was employed, with a frequency of 100 Hz, pulse width of 500 µs, Ton 5 s, Toff 25 s, ramp up of 1 s and ramp down of 1 s.
| Study group | Role | What they receive |
|---|---|---|
| Branched-chain Amino Acid (BCAA) group | Experimental | branched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag.
frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral \& parenteral.
duration: 10 days standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day Receives: Dietary Supplement: BCAA; Other: Standard nutrition; Other: Standard physiotherapy |
| Control group | Placebo comparator | No placebo. Not given intervention product. standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day Receives: Other: Standard nutrition; Other: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Quadriceps femoris dextra muscle thickness between groups at baseline and end of study
Measured: 10 days
Secondary outcomes (1)
Interleukin-6
Interleukin-6 levels between groups at baseline and end of study
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start14 Dec 2023
- Primary completion10 May 2024
- Study completion10 May 2024
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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Yohannessa Wulandari, M.Gizi, Sp GK, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167772
- Sponsor's protocol ID
- 23-09-1478
- Acronym
- SOFA
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wulandari Y, Aditianingsih D, Sunardi D, Prasetyo M, Madjid AS, Nusdwinuringtyas N, Sutanto LB, Hardy G. High leucine branched-chain amino acids supplementation ameliorates quadriceps femoris muscle thickness reduction and attenuates interleukin-6 in critically ill patients: A randomised controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102833. doi: 10.1016/j.clnesp.2025.11.153. Epub 2025 Nov 29.
PubMed 41325937
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, and Sequential Organ Failure Assessment Score in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06167772
- Acronym / sponsor ID
- SOFA / 23-09-1478
- Conditions
- Critical Illness, Muscle Wasting
- Keywords
- Leucine, Branched-chain amino acid, Muscle wasting, Critically-ill patients, Muscle thickness, Interleukin-6, Sequential organ failure assessment score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 13 Dec 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.
The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study.
Detailed description
The goal of this clinical trial study is to test effects of leucine-enriched branched-chain amino acid (BCAA) in critically ill patients. The main questions it aims to answer are: • How are the changes in muscle thickness between groups at baseline and end of study • Is there a decrease in interleukin-6 levels between groups at baseline and end of study • Is there a decrease in sequential organ failure assessment score between groups at baseline and end of study. Participants will be given leucine-enriched branched-chain amino acid 40 g/day enterally or parenterally for 10 days. Researchers will compare with control groups to see if there is any changes between groups at baseline and end of study. Both groups will be given standard nutrition with target energy of 20 kcal/kg bodyweight(BW)/day and ratio of nitrogen:non-protein calorie 1:70 and neuromuscular electrical stimulation 30 minutes per day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branched-chain Amino Acid (BCAA) group | Experimental | Dietary Supplement: BCAA, Other: Standard nutrition, Other: Standard physiotherapybranched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag. frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral \& parenteral. duration: 10 days standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day |
| Control group | Placebo comparator | Other: Standard nutrition, Other: Standard physiotherapyNo placebo. Not given intervention product. standard nutrition: oral nutrition supplement (high protein) or parenteral with target energy of 20 kcal/kg BW/day standard neuromuscular electrical stimulation 30 minutes per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- new admission to intensive care unit (ICU) in first 24 hours
- aged 18-65 years
- SOFA score >= 4
Key exclusion criteria (8 listed)
- pregnant
- ultrasound examination cannot be performed under these circumstances: deformities, open wounded, prosthetics on right leg, amputated above right patella
- body mass index <16 kg/m2
- chronic kidney disease stage 3-5
- diabetes mellitus uncontrolled blood glucose (BG) (BG >200 mg/dL)
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 |
|---|---|---|
| BCAAbranched-chain amino acid (bcaa) (ratio valine:leucine:isoleucine = 1.2:2:1) 40 g/day (leucine 19 g/day) form: powdered bcaa sealed in 8 g sachet package or bcaa parenteral 250 mL per bag. frequency: 1 sachet bcaa dissolved in oral nutrition supplement (standard nutrition) 5 times per day, or bcaa parenteral, or combination of bcaa enteral \& parenteral. duration: 10 days | Dietary supplement | Branched-chain Amino Acid (BCAA) group |
| Standard nutritionAlso: High protein oral nutritional supplementationTarget energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70 | Other | Branched-chain Amino Acid (BCAA) group, Control group |
| Standard physiotherapyAlso: Neuromuscular electrical stimulationA symmetric biphasic rectangular pulse was employed, with a frequency of 100 Hz, pulse width of 500 µs, Ton 5 s, Toff 25 s, ramp up of 1 s and ramp down of 1 s. | Other | Branched-chain Amino Acid (BCAA) group, Control group |
Primary outcome
Muscle thickness
Time frame: 10 days
Quadriceps femoris dextra muscle thickness between groups at baseline and end of study
1 secondary outcome
Interleukin-6
Time frame: 10 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 23 Jul 2024.
- Derived from this study: PubMed 41325937Wulandari Y, Aditianingsih D, Sunardi D, Prasetyo M, Madjid AS, Nusdwinuringtyas N, Sutanto LB, Hardy G. High leucine branched-chain amino acids supplementation ameliorates quadriceps femoris muscle thickness reduction and attenuates interleukin-6 in critically ill patients: A randomised controlled trial. Clin Nutr ESPEN. 2026 Apr;72:102833. doi: 10.1016/j.clnesp.2025.11.153. Epub 2025 Nov 29.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA, Standard nutrition and Standard physiotherapy in people with Critical Illness and Muscle Wasting, run by Universitas Indonesia at 2 sites in Indonesia.
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 3 inclusion and 8 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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. Some participants in this study may receive a placebo. 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?
Muscle thickness (time frame: 10 days). 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 NCT06167772, 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 23 Jul 2024.