Clinical Trial: Intensive Supervised Nutritional Therapy Versus Guideline‐Based Nutritional Advice for Sarcopenia in Decompensated Cirrhosis—A Randomised Controlled Trial

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ABSTRACT Background Sarcopenia is highly prevalent in decompensated cirrhosis and independently predicts adverse outcomes. Although nutritional therapy is guideline‐recommended, evidence comparing specialist dietitian‐supervised nutritional care with routine physician‐delivered dietary advice remains limited. Aim To compare the efficacy of dietitian‐supervised intensive nutritional therapy with physician‐led guideline‐based dietary advice for improving skeletal muscle mass, strength and physical performance in patients with decompensated cirrhosis and sarcopenia. Methods In this single‐centre, open‐label, randomised controlled trial, 180 patients with decompensated cirrhosis and sarcopenia were randomised (1:1) to dietitian‐supervised intensive nutritional therapy or physician‐led guideline‐based dietary advice for 6 months. The intervention targeted energy intake of 35–40 kcal/kg/day and protein intake of 1.2–1.5 g/kg/day through structured dietitian supervision. The primary outcome was change in skeletal muscle index (SMI); secondary outcomes included handgrip strength (HGS), gait velocity, nutritional status, liver disease severity and clinical outcomes. Results Dietitian‐supervised therapy produced significantly greater improvements than physician‐led care in SMI (between‐group difference +2.50 cm 2 /m 2 ; 95% CI 1.30–3.70), HGS (men: +7.5 kg, 95% CI 5.39–9.61; women: +4.8 kg, 95% CI 3.12–6.48) and gait velocity (+0.23 m/s; 95% CI 0.13–0.33) (all p < 0.001). Serum albumin increased (+0.48 g/dL between groups) and CTP score improved (−1.30 points), whereas MELD score remained unchanged. Overall multidomain response occurred in 68.9% versus 37.8% of participants (RR 1.82, 95% CI 1.36–2.44; number needed to treat 3.2). Dietitian‐supervised therapy independently predicted SMI response (OR 3.82; 95% CI 1.80–8.10). No significant differences were observed in mortality, hospitalisation or other major clinical events. Conclusions In patients with decompensated cirrhosis and sarcopenia, dietitian‐supervised intensive nutritional therapy produced greater improvements in skeletal muscle mass, strength and physical performance than routine physician‐led guideline‐based dietary advice. Trial Registration CTRI number ( www.ctri.nic.in ): CTRI/2023/12/060881