Pilot trial finds no between-group muscle mass benefit from HMB supplement in cirrhosis sarcopenia
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Key Takeaway
Interpret within-group improvements in pilot HMB trial for cirrhosis sarcopenia with caution; no between-group benefit seen.
This pilot randomized controlled trial evaluated a 12-week intervention with a daily HMB-containing oral nutritional supplement (providing 1.48 g Calcium HMB, 21 g protein, and 524 kcal) compared to maltodextrin in 21 patients with stable decompensated cirrhosis and sarcopenia. The primary outcome was change in muscle mass measured by bioelectrical impedance analysis.
For the primary outcome and key secondary measures, the study found no significant between-group differences in muscle mass parameters (e.g., appendicular skeletal muscle mass index) or handgrip strength. However, within the HMB group, significant within-group improvements from baseline were observed for phase angle (from 4.6° to 5.0°, p=0.015), mid-arm muscle circumference (from 23.3 cm to 24.4 cm, p=0.008), and 5-time chair stand test performance (from 18.6 s to 16.5 s, p=0.047).
The intervention was reported as well-tolerated with no significant adverse events, though serious adverse events and discontinuation rates were not reported. Key limitations include the pilot nature of the trial and the very small sample size of 21 patients, which severely limits statistical power and generalizability.
Given the lack of significant between-group differences for the primary outcome and the preliminary nature of the evidence, these findings should be interpreted with caution. The observed within-group signals of improvement in some parameters require validation in larger, adequately powered randomized controlled trials before any clinical conclusions can be drawn.
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View Original Abstract ↓
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/).
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