The effects of beta-hydroxy-beta-methylbutyrate on sarcopenia in stable decompensated cirrhosis: A pilot randomized controlled trial.

HMB-containing ONS did not produce significant between-group differences in muscle mass parameters compared to maltodextrin control at 12 weeks.

• Primary outcome was 12-week change in muscle mass measured by bioelectrical impedance analysis (BIA).
• No significant between-group differences were found in appendicular skeletal muscle mass index (ASMI) or fat-free mass index (FFMI).
• The trial was a pilot randomized controlled trial with 21 participants total (HMB group n=12, control group n=9).
• The control group received maltodextrin as comparator.

The HMB group demonstrated significant within-group improvement in phase angle from baseline to 12 weeks.

• Phase angle improved from 4.6° to 5.0° (p = 0.015) within the HMB group.
• Phase angle measured by bioelectrical impedance analysis is considered a marker of muscle quality.
• This was a within-group comparison, not a between-group comparison.

The HMB group demonstrated significant within-group improvement in mid-arm muscle circumference (MAMC) from baseline to 12 weeks.

• MAMC improved from 23.3 cm to 24.4 cm (p = 0.008) within the HMB group.
• MAMC is an anthropometric measure used as a secondary outcome.
• This was a within-group comparison, not a between-group comparison.

The HMB group demonstrated significant within-group improvement in 5-time chair stand test performance from baseline to 12 weeks.

• 5-time chair stand test time improved from 18.6 seconds to 16.5 seconds (p = 0.047) within the HMB group.
• The chair stand test is a measure of physical performance.
• This was a within-group comparison, not a between-group comparison.

Handgrip strength did not show significant between-group differences at 12 weeks.

• Handgrip strength was a secondary outcome measured at 12 weeks.
• No significant between-group difference was found for handgrip strength.
• This finding was consistent with the lack of significant between-group differences in muscle mass parameters.

The HMB-containing ONS intervention was well-tolerated with no significant adverse events in patients with stable decompensated cirrhosis.

• Participants received a daily total of 1.48 g Calcium HMB, 21 g protein, and 524 kcal for 12 weeks.
• No significant adverse events were reported in the HMB group.
• The study population consisted of patients with stable decompensated cirrhosis and sarcopenia.

This was a pilot randomized controlled trial enrolling patients with stable decompensated cirrhosis and sarcopenia over approximately 21 months.

• Enrollment occurred from April 2022 to January 2024.
• 21 patients total were randomized: HMB group (n=12) and control group (n=9).
• Patients received either HMB-containing ONS or maltodextrin for 12 weeks.
• The trial was registered in the Thai Clinical Trials Registry (No. TCTR20240422012).