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

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 cm2/m2; 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.