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Effects of beta-hydroxy-beta-methylbutyrate supplementation in decompensated cirrhosis patients with sarcopenia: Randomize controlled trial, Preliminary Study

The Effects of beta-hydroxy-beta-methylbutyrate supplementation in decompensated cirrhosis patients with sarcopenia: Randomize controlled trial, Preliminary Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240422012
Enrollment
60
Registered
2024-04-22
Start date
2023-04-25
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

Decompensated cirrhosis is associated with poor outcomes, especially when combined with sarcopenia. Cirrhosis, Sarcopenia, Beta-hydroxy beta-methylbutyrate

Interventions

Each serving provides 262 kcal, 10.5 g protein, 8.48 g fat, 34.2 g carbohydrate, 7.75 mcg (310 IU) Vitamin D3, and 0.74 g calcium HMB. 6 scoops mixed with 185 ml of water, twice a day morning and onc
HMB group,standard treatment group

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged more than 18-years-old 2. Decompensated cirrhosis cirrhosis includes either of the following criteria - liver biopsy or - history of complications related to cirrhosis, such as ascites, variceal bleeding, hepatic encephalopathy or - meeting 2 out of 4 criteria of transient elastography > 13 kPa, radiological assessments showing features consistent with cirrhosis (enlarged liver, dilated portal veins, or the presence of ascites), APRI greater than 2.0, and EGD revealing signs of varices. - Decompensated cirrhosis is defined by the presence or history of overt PHT-related bleeding, ascites of at least grade 2, overt hepatic encephalopathy, or a Child-Pugh score of B or C. 3. Sarcopenia criteria by the Asian Working Group for Sarcopenia and the extended criteria of reduced muscle mass use a threshold in international criteria

Exclusion criteria

Exclusion criteria: 1. active cancer 2. untreated chronic hepatitis B or C 3. alcohol consumption within the past 6 months 4. severe active infections 5. chronic kidney disease (CKD) stage 4 or 5 6. uncontrolled diabetes defined by HbA1C > 9% 7. active heart failure defined by New York Heart Association (NYHA) class III or IV 8. chronic obstructive pulmonary disease GOLD C or D 9. limitations for conducting bioelectrical impedance analysis (BIA) measurements presence of metal implants in the body, limb disability or amputation, pregnancy, use of a cardiac pacemaker or implantable cardiac resynchronization therapy 10. post-liver transplantation (LT) or LT waiting list 11. Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4 12. ascites grade 3 or refractory ascites 13. recent spontaneous bacterial peritonitis or gastrointestinal bleeding, or hepatic encephalopathy within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Muscle mass 12 week, 24 week bioelectrical impedance analysis (BIA)

Secondary

MeasureTime frame
muscle performance ,muscle strength, body composition 12 week, 24 week bioelectrical impedance analysis (BIA),the rate of hospitalization, decompensated events, and mortality 12 week, 24 week questionnaire interview

Countries

Thailand

Contacts

Public ContactJittirat Jinchai

Faculty of Medicine, Khon Kaen University

Jittiratjinchai@gmail.com66868514232

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026