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Enhancing Muscle Recovery after Critical Illness with BetaHydroxy-Beta-Methylbutyrate(HMB): A randomized controlled trial

Enhancing Muscle Recovery after Critical Illness with BetaHydroxy-Beta-Methylbutyrate(HMB): A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251212011
Enrollment
32
Registered
2025-12-12
Start date
2025-12-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recovery after Critical Illness Critical Illness Muscle mass BetaHydroxy-Beta-Methylbutyrate(HMB) A randomized controlled trial

Interventions

Participants will receive enteral nutrition (EN) enriched with 398 Beta-Hydroxy-Beta-Methylbutyrate (HMB) which contain 1.5-6 gm of Ca-HMB,Participants will receive conventional enteral nutrition with
HMB group,Conventional group

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged more than 20 2. On enteral feeding dose of more than 20 kcal per kg per day 3. Resolution or stabilization of the primary acute condition (e.g.,sepsis, ARDS, major surgery). o In a step-down setting (VDU, intermediate care in ICU, post ICU discharge to medical wards within 14 days) o Still in ICU but in the weaning phase of mechanical ventilation, characterized by: - Spontaneous breathing trials (SBTs) being conducted. - On low levels of ventilator support (e.g., pressure support less than 10 cmH2O above CPAP, CPAP less than 8 cmH2O). - FiO2 less than 0.4 - Hemodynamic stability: No or minimal vasopressor, inotropic support (e.g., norepinephrine less than 0.2 mcg per kg per min or equivalent doses of other vasopressors). - Not requiring deep sedation or neuromuscular blockade. - Prolonged mechanical ventilator more than 7 days - Clinical frailty scale 4-6 - NT 2-3 - Expected NG insertion more than 14 days 4. No contraindications to enteral feeding or feeding intolerance requiring intervention (i.e., prokinetic, NPO, TPN, or surgical intervention) 5. Expected to remain in hospital for more than 72 hours post - enrollment.

Exclusion criteria

Exclusion criteria: 1. Pre-existing muscle-wasting diseases (e.g., muscular dystrophy, advanced cancer, cachexia, patient who diagnosed with amyotrophic lateral sclerosis (ALS), myasthenia gravis, multiple sclerosis, or chronic inflammatory demyelinating polyneuropathy (CIDP).) 2. End-stage liver disease (Child-Pugh class C) 3. Terminal illness or palliative care focus 4. CKD that eGFR less than 30 or dialysis dependent (The nitrogen balance cannot be reliably calculated in patients with severe renal dysfunction because urinary urea excretion (UUN) is altered 5. Obesity (BMI more than 40) 6. Pregnancy or lactation 7. Absence of consent

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of HMB EN feeding on muscle preservation in critically ill patients within 14-28 days 14 days Thigh muscle CSA and muscle thickness

Secondary

MeasureTime frame
To evaluate the effect of HMB EN feeding on muscle preservation in critically ill patients within 14-28 days 14 days Thigh muscle CSA and muscle thickness,To assess the effects of HMB EN feeding 14 days and 28 days serum albumin and total protein levels,To determine the influence of HMB EN feeding End of study Length hospitalization,To observe the new onset End of study hospital-acquired infections

Countries

Thailand

Contacts

Public ContactKawin Wattanakoon

Faculty of Medicine, Chiang Mai University

kawin.wat@cmu.ac.th053935482

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026