Intradialytic Oral Protein Supplementation and Nutritional and Inflammation Outcomes in Hemodialysis: A Randomized Controlled Trial

Background Malnutrition is a common finding in hemodialysis patients and can increase oxidative stress and inflammation levels. Study Design A randomized, controlled, nonblinded, parallel trial. Setting & Participants 92 hemodialysis patients from a single center with malnutrition according to subjective global assessment (SGA) score (SGA score > 7). Intervention 3 treatment groups (23 patients each) received 220 mL of fermented vitamin E−fortified whey beverage (15 g of whey protein concentrate + 600 IU of vitamin E) or 220 mL of fermented whey beverage (15 g of whey protein concentrate) or vitamin E (600 IU) 3 times a week for 8 weeks. The control group (23 patients) received no intervention. Outcome & Measurements Primary outcomes were change in SGA score and malnutrition-inflammation score (MIS) from baseline to the end of the trial. Results At the end of the study, 83 patients were analyzed (2, 3, 1, and 3 patients left the study in the vitamin E–fortified whey beverage, whey beverage, vitamin E, and control groups, respectively). Changes in SGA scores were −3.48 (95% CI, −4.90 to −2.00), −3.22 (95% CI, −4.13 to −2.30), −1.70 (95% CI, −3.20 to −0.24), and 1.56 (95% CI, 0.60 to 2.50) for the vitamin E–fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P < 0.001; P ≤ 0.001 for each treatment group vs control). Changes in MISs were −3.17 (95% CI, −4.40 to −1.90), −1.83 (95% CI, −2.50 to −1.10), −2.30 (95% CI, −3.50 to −1.10), and 1.48 (95% CI, 0.65 to 2.30) for the vitamin E–fortified whey beverage, whey beverage, vitamin E, and control groups, respectively (overall P < 0.001; P < 0.001 for each treatment group vs control). Few adverse effects were reported in any group. Limitations Lack of blinding, small sample size, and short duration. Conclusions Whey protein in the form of a new fermented whey beverage and vitamin E supplementation may improve SGA score and MIS in the short term.