Leucine-enriched Branched-chain Amino Acid on Muscle Thickness, Interleukin-6, SOFA Score in Critical Illness

NCT06167772 | Completed DMC

• 1 other identifier: 23-09-1478
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• Muscle thickness

  Quadriceps femoris dextra muscle thickness between groups at baseline and end of study

  10 days

Secondary Outcomes (1)

• Interleukin-6

  10 days

Other Outcomes (1)

• Sequential Organ Failure Assessment Score

  10 days

Study Arms (2)

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

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

Other: Standard nutrition; Other: Standard physiotherapy

Interventions

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

Branched-chain Amino Acid (BCAA) group

Standard nutrition OTHER

Target energy of 20 kcal/kg BW/day Target protein ratio protein:non-protein calorie 1:70

Also known as: High protein oral nutritional supplementation

Branched-chain Amino Acid (BCAA) group; Control group

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.

Also known as: Neuromuscular electrical stimulation

Branched-chain Amino Acid (BCAA) group; Control group

Eligibility Criteria

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

You may qualify if:

• new admission to intensive care unit (ICU) in first 24 hours
• aged 18-65 years
• SOFA score \>= 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Universitas Indonesia Hospital

Depok, West Java, Indonesia

Location

Related Publications (1)

• 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. 2025 Nov 29:102833. doi: 10.1016/j.clnesp.2025.11.153. Online ahead of print.

  PMID: 41325937 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical nutrition specialist; PhD student

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 13, 2023
• Study Start: December 14, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

ID (2)