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

BACKGROUND AND OBJECTIVE: The effectiveness of beta-hydroxy-beta-methylbutyrate (HMB) for sarcopenia in decompensated cirrhosis patients remains unclear. This pilot trial investigated the effect of HMB-containing oral nutritional supplement (ONS) on muscle mass as the primary outcome. Secondary outcomes included changes in muscle strength, quality, and physical performance. METHODS: This randomized controlled trial included 21 patients with stable decompensated cirrhosis and sarcopenia (April 2022-January 2024). Participants received either an HMB-containing ONS (daily total of 1.48 g Calcium HMB, 21 g protein, 524 kcal) (HMB group, n = 12) or maltodextrin (control group, n = 9) for 12 weeks. The primary outcome was the 12-week change in muscle mass measured by bioelectrical impedance analysis. Secondary outcomes included handgrip strength, anthropometry, and physical performance. RESULTS: At 12 weeks, there were no significant between-group differences in muscle mass parameters (e.g., appendicular skeletal muscle mass index [ASMI], fat-free mass index [FFMI]) or handgrip strength. However, the HMB group demonstrated significant within-group improvements from baseline in phase angle (4.6°-5.0°, p = 0.015), mid-arm muscle circumference [MAMC] (23.3-24.4 cm, p = 0.008), and 5-time chair stand test performance (18.6-16.5 s, p = 0.047). The supplement was well-tolerated with no significant adverse events. CONCLUSION: In patients with stable decompensated cirrhosis and sarcopenia, 12-week HMB-containing ONS was well-tolerated. While it did not significantly increase muscle mass or handgrip strength compared to the control group, HMB-containing ONS showed promise for improving key sarcopenia-related parameters-phase angle, mid-arm muscle circumference, and chair stand test performance when compared to baseline. Larger adequately powered randomized controlled trials are needed to confirm these findings. (Trial Registration: Thai Clinical Trials Registry on April 22, 2024, No. TCTR20240422012. The registration can be accessed at: https://thaiclinicaltrials.org/).