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

Abstract

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<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.

Keywords: Protein supplementation; antioxidant; end-stage renal disease (ESRD); hemodialysis; malnourishment; malnutrition-inflammation complex syndrome (MICS); malnutrition-inflammation score (MIS); randomized controlled trial; subjective global assessment (SGA); vitamin E; whey protein.