Effects of oral non-protein calorie supplements on nutritional status among maintenance hemodialysis patients with protein-energy wasting: a multi-center randomized controlled trial.

Protein-energy wasting (PEW) is prevalent in maintenance hemodialysis (MHD) patients, and is one of the major risk factors for poor outcomes and death. This study aimed to investigate the effects of non-protein calorie supplements on the nutritional status of MHD patients with PEW. MHD patients with PEW were enrolled in this multi-center, open-label, randomized controlled trial. Then, they were randomly assigned to the intervention group to receive the non-protein calorie supplements containing 280 kcal of energy every day for 6 months or the control group to complete all aspects of the study without receiving supplements. Patients in both groups received dietary counselling from dietitians. Data on nutritional assessments, anthropometric measurements, blood analysis and dietary recall were collected at the baseline and at six months from both groups. Statistical analyses were performed using analysis of covariance (ANCOVA) adjusted for sex and baseline values. Ninety-two MHD patients completed the study. A significant increase in the subjective global assessment (SGA) score was found in the intervention group compared with the control group (4.88 ± 1.41 4.40 ± 1.16, = 0.044). The ratio of PEW patients (diagnosed with SGA ≤5) in the intervention group (61.2%) was also significantly lower than that in the control group (83.7%) ( < 0.001). Moreover, significant improvements in body mass index (20.81 ± 2.46 kg m 19.51 ± 2.60 kg m, < 0.001), nutrition risk screening 2002 (2.45 ± 1.40 3.12 ± 1.37, = 0.038), mid-upper arm circumference (23.30 ± 2.78 cm 21.75 ± 2.87 cm, = 0.001), and mid-arm muscle circumference (20.51 ± 2.32 cm 19.06 ± 2.92 cm, = 0.005) were observed in the intervention group compared with the control group. Patients in the intervention group took in more dietary energy than the control group (26.96 ± 4.75 kcal per kg body weight per day 24.33 ± 2.68 kcal per kg body weight per day, < 0.001). In conclusion, non-protein calorie supplements may improve the nutritional status of MHD patients with PEW.