A pilot study on the impact of Hydroxiram D supplementation on nutritional status and sarcopenia-related parameters

Sarcopenia is a frequent and prognostically relevant complication of chronic liver disease. The SARCIRAM pilot trial investigated the effect of Hydroxiram D, a formulation of branched-chain amino acids (BCAAs), β-hydroxy-β-methylbutyrate (HMB), and vitamin D, on nutritional status and sarcopenia-related parameters in patients with compensated cirrhosis due to metabolic dysfunction-associated steatotic liver disease (MASLD). In this single-center, randomized pilot study, adults with compensated MASLD-related cirrhosis (Child-Pugh A) received Hydroxiram D plus standard care or standard care alone for 6 months. The primary outcome was phase angle (PA), while secondary outcomes were appendicular skeletal muscle mass (ASMM)/height², handgrip strength (HGS), and 4-meter walk test (4-mWT). Between-group comparisons used baseline-adjusted models. Post-hoc simulation analyses were used exploratorily to inform the design of future studies. Thirty-two patients were analyzed. After 6 months, the adjusted change in PA was significantly more favorable in the treated group versus controls (+ 0.36° vs. − 0.45°, p = 0.046). Between-group differences in muscle mass, HGS, and gait speed were not statistically significant, although effect estimates directionally favoured the intervention. No treatment-related adverse events were observed. Six months of Hydroxiram D was associated with a more favorable change in PA in patients with compensated MASLD-related cirrhosis, with favorable trends in muscle parameters. These hypothesis-generating findings warrant confirmation in larger, prospectively registered, double-blind trials to confirm efficacy and long-term outcomes.