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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCAA | Dietary 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle thickness | Quadriceps femoris dextra muscle thickness between groups at baseline and end of study | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 | Interleukin-6 levels between groups at baseline and end of study | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sequential Organ Failure Assessment Score | Sequential Organ Failure Assessment Score between groups at baseline and end of study on scale 0-24 | 10 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia | ||
| Universitas Indonesia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41325937 | Derived | 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. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
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| Standard nutrition | Other | Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70 |
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| Standard physiotherapy | Other | 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. |
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| Depok |
| West Java |
| Indonesia |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |