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 220mL of fermented vitamin E−fortified whey beverage (15g of whey protein concentrate + 600IU of vitamin E) or 220mL of fermented whey beverage (15g of whey protein concentrate) or vitamin E (600IU) 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 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 P 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.