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A Randomized, Double-Blind, Crossover Pilot Trial of Rice Endosperm Protein Supplementation in Maintenance Hemodialysis Patients.

  • 2017-12-21
  • Scientific reports 7(1)
    • Michihiro Hosojima
    • Hisaki Shimada
    • Yoshitsugu Obi
    • Shoji Kuwahara
    • Ryohei Kaseda
    • Hideyuki Kabasawa
    • Hazuki Kondo
    • Mikio Fujii
    • Reiko Watanabe
    • Yoshiki Suzuki
    • Motoni Kadowaki
    • Shigeru Miyazaki
    • Akihiko Saito

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 24
Population
50 Japanese adult MHD patients (1 dropped out)
Methods
randomized, double-blind, placebo-controlled, crossover pilot study of REP supplementation (5 g/day × 4 weeks)
Blinding
Double-blind
Duration
4 weeks
  • Rigorous Journal
In maintenance hemodialysis (MHD) patients, low protein intake is associated with protein-energy wasting, a risk factor that affects outcome. However, increased protein intake may lead to hyperphosphatemia and hyperkalemia, which are also mortality risk factors. Here, we evaluated the safety and effects of purified rice endosperm protein (REP), which contains less phosphorus and potassium than soy and casein proteins, as a supplemental protein source for MHD patients. This randomized, double-blind, placebo-controlled, crossover pilot study of REP supplementation (5 g/day × 4 weeks) was carried out in 50 Japanese adult MHD patients (1 dropped out); the primary outcome was the change in the urea kinetic-based normalized protein catabolic rate (nPCR), an indicator of protein intake in MHD patients. Intention-to-treat analyses of 24 patients in the REP-first group and 25 in the placebo-first group showed that REP supplementation increased nPCR significantly by 0.07 g/kg/day (95% confidence interval, 0.03-0.11), whereas changes in serum phosphorus and potassium concentrations were not different from the placebo. REP supplementation did not show a significant effect on other nutritional or metabolic parameters and no specific complications. In conclusion, purified REP with efficient bioavailability may be safe and useful for dietary supplementation in MHD patients.

Research Insights

Adverse Events Reported

  • Rice Protein→hyperkalemia

    changes in serum phosphorus and potassium concentrations were not different from the placebo.

    Finding
    No significant difference
    Significant
    Yes
  • Rice Protein→hyperphosphatemia

    changes in serum phosphorus and potassium concentrations were not different from the placebo.

    Finding
    No significant difference
    Significant
    Yes
  • Rice Protein→Overall tolerability

    REP supplementation did not show a significant effect on other nutritional or metabolic parameters and no specific complications.

    Finding
    Reported
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