title: 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.
  
  
  METHODS
  A randomized, controlled, nonblinded, parallel trial.
  
  
  METHODS
  92 hemodialysis patients from a single center with malnutrition according to subjective global assessment (SGA) score (SGA score > 7).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Sohrabi
authors.affiliation: Clinical Nutrition Department, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: h_eftekhari@yahoo.com.
authors.forename: Mohammad Hassan
authors.initials: MH
authors.lastname: Eftekhari
authors.affiliation: Department of Food Science and Technology, School of Agriculture, Shiraz University, Shiraz, Iran.
authors.forename: Mohammad Hadi
authors.initials: MH
authors.lastname: Eskandari
authors.affiliation: Department of Epidemiology, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Abbas
authors.initials: A
authors.lastname: Rezaianzadeh
authors.affiliation: Nephrology Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Mohammad Mahdi
authors.initials: MM
authors.lastname: Sagheb
mesh_terms: D001628:Beverages; D004044:Dietary Proteins / Q000008:administration & dosage*; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007249:Inflammation / Q000209:etiology / Q000517:prevention & control; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D044342:Malnutrition / Q000209:etiology / Q000517:prevention & control; D008875:Middle Aged; D009752:Nutritional Status; D006435:Renal Dialysis
chemical_list: D004044:Dietary Proteins
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