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Efficacy of low-protein rice for dietary protein restriction in CKD patients: A multicenter randomized controlled study

Background: The benefits of dietary protein restriction in chronic kidney disease (CKD) remain unclear, largely due to inadequate adherence in most clinical trials. We examined whether low-protein rice (LPR), previously developed to reduce the protein content of rice, as a major staple food, would help improve adherence to dietary protein restriction. Methods: This open-label multicenter randomized controlled trial evaluated the efficacy of LPR use for reducing dietary protein intake (DPI) in patients with CKD stages G3aA2 to G4. Participants were randomly assigned in a 1:1 ratio to an LPR or control group and were followed up for 24 weeks. Both groups received regular counseling by dietitians to help achieve a target DPI of 0.7 g/kg ideal body weight (IBW)/day. The amount of protein in LPR is about 4% of that in ordinary rice, and the participants in the LPR group were instructed to consume LPR with at least two meals/day. The primary outcome was estimated DPI (eDPI) determined using Maroni's formula. The secondary outcomes included creatinine clearance (CCr) and urinary protein based on 24-h urine collection. Results: In total, 51 patients were randomized either to the LPR group or control group. At baseline, mean age was 62.5 years, 70% were men, mean CCr was 52.0 mL/min, and mean eDPI was 0.99 g/kg IBW/day. At 24 weeks, mean eDPI decreased to 0.80 g/kg IBW/day in the LPR group and to 0.91 g/kg IBW/day in the control group, giving a between-group difference of 0.11 (95% confidence interval, 0.03-0.19) g/kg IBW/day (P=0.006). There was no significant between-group difference in CCr, but urinary protein was lower at 24 weeks in the LPR group than in the control group. Conclusions: LPR is a feasible tool for efficiently reducing DPI in CKD patients.