Safety And Efficacy Of Dislodged Protein Rice On Patients With Advanced Chronic Kidney Disease :a Clinical Prospective Study

Objectives:To evaluate the efficacy, safety and compliance of dislodged protein rice on delaying the progression of advanced chronic kidney disease.Methods:Form Oct, 2014 to Jan, 2016,the patients were diagnosed as advanced chronic renal disease who regularly visited the outpatient department of Guangzhou Red Cross Hospital for enrollment.41 of patients participated in this study and 36 of them finished the 12 month follow-up. All participants were randomly divided into two groups, dislodged protein rice group(DPR)and control group(Contr) according to random number table. The DPR group staple food is dislodged protein rice and Contr group staple food is wheat starch. Both groups were given nutrition education and received a total caloric intake of 30 to 35 kcal/kg /day. All patients were recommended to adhere low protein diet(protein 0.6g/kg/d) plus Ketoanalogues tablets(0.12g/kg/d). During the time of 0,1,3,6 and 12 month after intervention, diet intaking, complains, anthropometry, routine blood test, blood biochemical parameters,and 24 hour urinary urea nitrogen(UUN), urinary protein were checked in two groups.The change of e GFR, blood urea nitrogen( BUN), serum creatinine(SCr), diet protein intake,Urine protein, renal death of patients were used to assess the effectiveness, the nutritional status were used to evaluate the safety, and diet protein intake and numbers of patients who can adhere to low protein diet were used to assess the compliance of patients.Results:(1)There was no difference in baseline values between two groups in Disease composition ratio, age, sex, body mass index, blood hemoglobin(Hb), e GFR, serum creatinine, usea nitrogen, uric acid,hypersensitive C-reactive protein( Hs CRP),Parathyroid hormone(PTH),24 hour urinary protein, drugs intake,diet protein intake(DPI)and calories intake.No obvious side effects were recorded during the patients who finished the 12 months follow-up.(2) Alories intake did not significant changed between two groups(p>0.05).Therewas no statistical difference in daily protein intake between DPR group and standard protein intake(0.6g/kg/d).Compared with standard protein intake,group Contr showed a significant higher DPI form 3 months to the end(P<0.05).There was no difference in the final number of participants between the two groups(83%vs90%,P>0.05). the number of CKD patients who reached low protein diet is significantly lower in Contr group, when compared with DPR group(33%vs83%,P<0.05).(3) Compared with the group Contr,group DPR showed a significant higher e GFR at the end of the study(P<0.05).Throughout the study, the DPR group showed no significantly different serum creatinine、usea nitrogen and uric acid when compared with Contr group(P>0.05);The uric acid show no significant increased between two groups(P>0.05). DPR group presented no significant decreased in e GFR throughout the study(P>0.05).The serum creatinine 、usea nitrogen and uric acid show no significant increased between each period in DPR group( P>0.05).Contr group presented a significantly decreased e GFR from the 6th month to the end(P<0.05).The serum creatinine and usea nitrogen show significant increased at the end of the study in Contr group(P<0.05);The uric acid show no significant increased between each period in Contr group(p>0.05).(4)Compared with the group DPR,group Contr showed a significant higher Urine protein form 3 months to the end(P<0.05). There was significant decreased in Urine protein at the end of the study in DPR group(P<0.05).There was no significant decreased in Urine protein throughout the study in Contr group(P>0.05).(5)Compared with the Contr group,DPR group showed a significant higher CO2-CP form 3 months to the end(P<0.05).There was no significant increased in carban dioxide-combining Power(CO2-CP) throughout the study in DPR group.There was significant decreased in CO2-CP at the end of the study in Contr group.(6)Compared with the Contr group,DPR group showed a significant higher The blood calcium form 3 months to the end( P<0.05). Contr group showed a significantly higher blood phosphorus in the end of the study when compared with the group DPR( P<0.05).There was no difference in PTH between the two groups throughout the study(P>0.05).In 12 th months, DPR groups Show significant higherblood calcium compared with pre-treatment(P<0.05);However, the levels of blood phosphorus and PTH did not differ obviously in DPR groups(P>0.05).Intra-group comparisons of measures before and after the treatment in Contr group are as follows.The blood calcium show no significant difference between each period( P>0.05).However, the levels of blood phosphorus and PTH did differ obviously(P<0.05).(7)There was no difference in Hs CRP between the two groups throughout the study(P>0.05).There was no difference in Hs CRP throughout the study in DPR group(P>0.05).There was no difference in Hs CRP throughout the study in Contr group.(P>0.05).(8)Intra-group and Inter-group comparisons of measures before and after the treatment in two group: The body weight,BMI, albumin, prealbumin, triglyceride and cholesterol show no significant difference between each period( P> 0.05).Conclusions:1.The dislodged protein rice can improve patients’ compliance of low protein diet.in advanced chronic kidney disease.2.The dislodged protein rice can delay the progression of advanced chronic kidney disease.3.The dislodged protein rice can reduce urinary protein, improved metabolic acidosis and improved the disorder of calcium phosphate metabolism in advanced chronic kidney disease patients.4.The dislodged protein rice were safe in advanced chronic kidney disease patients.