Leucine-enriched chocolate supplementation in patients undergoing assessment for liver transplant: a randomized, double-masked, multicenter clinical trial.

OBJECTIVES: We conducted a randomized, double-masked, multicenter clinical trial to evaluate the incremental effect of leucine (LEU)-enriched chocolate supplementation (7.5 g of LEU/d for 12 wk) in addition to an active nutrition intervention on muscle strength in patients undergoing liver transplant (LTx) assessment. METHODS: Adult patients of both sexes with a diagnosis of cirrhosis and with a pre-LTx protocol completed or in progress at three LTx outpatient clinics were included. Clinical, nutritional, and functional data were collected at baseline (T0), after 6 wk (T6), and after 12 wk (T12). Data were analyzed according to the intention-to-treat approach. The effects of time and treatment on the primary and secondary outcomes were assessed using adjusted Generalized Estimating Equations models. RESULTS: The sample comprised 49 patients, 77.6% male, with a median age of 53.0 (47.0-60.0) years. No significant treatment effects were observed on muscle strength or on the secondary outcomes. However, dry body mass index (Δ 0.2 [-0.5 to 1.1] kg/m²), mid-arm circumference (Δ 0.5 [0.0-1.5] cm), triceps skinfold thickness (Δ 1.6 [0.0-2.7] mm), and adductor pollicis muscle thickness (Δ 0.7 [-0.8 to 2.8] mm) significantly increased over time, regardless of group allocation. CONCLUSIONS: LEU supplementation had no significant effect on muscle strength in patients with cirrhosis. However, the nutritional intervention and chocolate consumption over 12 wk increased anthropometric markers of muscle mass and adiposity. The study was registered in the Brazilian Registry of Clinical Trials (REBEC-RBR-9snttn).