Better preservation of residual renal function in peritoneal dialysis patients treated with a low-protein diet supplemented with keto acids: a prospective, randomized trial (original) (raw)

Treatment of chronic kidney disease patients with ketoanalogue-supplemented low-protein diet and ketoanalogue-supplemented very-low-protein diet

Hong Kong Journal of Nephrology, 2014

Introduction: A low-protein diet supplemented with ketoanalogues (KAs) has been shown to be effective in improving the benefits of a low-protein diet for patients with chronic kidney disease (CKD). Materials and methods: A total of 178 adult patients with CKD Stages 3e5 (predialysis) were assessed for 1 year. A total of 122 patients were in the KA-supplemented low-protein diet (sLPD) group and were prescribed 0.6 g/kg body weight (BW) of dietary proteins supplemented with one KA tablet for every 10 kg BW. The remaining 56 patients were in the KA-supplemented very-low-protein diet (sVLPD) group and received 0.3 g/kg BW of dietary protein supplemented with one KA tablet for every 5 kg BW. Renal, metabolic, and nutritional parameters, and anthropometric assessments were performed for all patients. Results: We assessed the renal function of the patients. There was no difference in the baseline clinical and laboratory characteristics between the sLPD and sVLPD groups. In the sLPD group, the blood urea level decreased from 85.38 AE 4.45 to 76.90 AE 42.90 mg/dL (p < 0.05) after 12 months. CKD stagewise assessment of the 24-hour urinary creatinine clearance (CrCl) showed an improving trend of renal function. In the sVLPD group, the blood urea level after 6 months decreased from 98.38 AE 42.97 to 79.84 AE 34.15 mg/dL (p < 0.05), but it increased to 102.74 AE 45.98 mg/dL (p > 0.05) at the end of 1 year. The CrCl showed a marginal increase at the end of 1 year, but this increase was not statistically significant. There was a decrease in urinary protein excretion in both groups. Anthropometric measurement, including Subjective Global Assessment, showed nutritional improvement in both groups. Pearson correlation coefficient between protein intake and urinary nitrogen appearance showed positive correlation between the two groups.

Ketoanalogue-Supplemented Vegetarian Very Low–Protein Diet and CKD Progression

Journal of The American Society of Nephrology, 2016

Dietary protein restriction may improve determinants of CKD progression. However, the extent of improvement and effect of ketoanalogue supplementation are unclear. We conducted a prospective, randomized, controlled trial of safety and efficacy of ketoanalogue-supplemented vegetarian very low-protein diet (KD) compared with conventional low-protein diet (LPD). Primary end point was RRT initiation or .50% reduction in initial eGFR. Nondiabetic adults with stable eGFR,30 ml/min per 1.73 m 2 , proteinuria ,1 g/g urinary creatinine, good nutritional status, and good diet compliance entered a run-in phase on LPD. After 3 months, compliant patients were randomized to KD (0.3 g/kg vegetable proteins and 1 cps/5 kg ketoanalogues per day) or continue LPD (0.6 g/kg per day) for 15 months. Only 14% of screened patients patients were randomized, with no differences between groups. Adjusted numbers needed to treat (NNTs; 95% confidence interval) to avoid composite primary end point in intention to treat and per-protocol analyses in one patient were 4.4 (4.2 to 5.1) and 4.0 (3.9 to 4.4), respectively, for patients with eGFR,30 ml/min per 1.73 m 2. Adjusted NNT (95% confidence interval) to avoid dialysis was 22.4 (21.5 to 25.1) for patients with eGFR,30 ml/min per 1.73 m 2 but decreased to 2.7 (2.6 to 3.1) for patients with eGFR,20 ml/min per 1.73 m 2 in intention to treat analysis. Correction of metabolic abnormalities occurred only with KD. Compliance to diet was good, with no changes in nutritional parameters and no adverse reactions. Thus, this KD seems nutritionally safe and could defer dialysis initiation in some patients with CKD.

Effect of Low-Protein Diet Supplemented with Keto Acids on Progression of Disease in Patients with Chronic Renal Failure

Nephron, 2000

Hypoproteic diets are most often discussed for patients with chronic kidney disease (CKD) who do not receive dialysis. A very low-protein diet supplemented with ketoanalogues of essential amino acids (keto-diet) proved effective in ameliorating metabolic disturbances of advanced CKD and delaying the initiation of dialysis without deleterious effects on nutritional status. Several recent studies report that the keto-diet could also slow down the rate of decline in renal function, with better outcomes after the initiation of dialysis. Results of a single-center randomized controlled trial addressing the rate of CKD progression revealed a 57% slower decline in renal function with the keto-diet compared with a conventional low-protein diet (LPD). The keto-diet allowed the safe management of selected patients with stage 4-5 CKD, delaying dialysis for almost 1 year, with a major impact on patient quality of life and health expenditures. Therefore, the keto-diet could be a link in the integrated care model. Careful selection of patients, nutritional monitoring, and dietary counseling are required.

Effect of Low-Protein Diet Supplemented With Keto Acids on Progression of Chronic Kidney Disease

Journal of Renal Nutrition, 2013

Hypoproteic diets are most often discussed for patients with chronic kidney disease (CKD) who do not receive dialysis. A very low-protein diet supplemented with ketoanalogues of essential amino acids (keto-diet) proved effective in ameliorating metabolic disturbances of advanced CKD and delaying the initiation of dialysis without deleterious effects on nutritional status. Several recent studies report that the keto-diet could also slow down the rate of decline in renal function, with better outcomes after the initiation of dialysis. Results of a single-center randomized controlled trial addressing the rate of CKD progression revealed a 57% slower decline in renal function with the keto-diet compared with a conventional low-protein diet (LPD). The keto-diet allowed the safe management of selected patients with stage 4-5 CKD, delaying dialysis for almost 1 year, with a major impact on patient quality of life and health expenditures. Therefore, the keto-diet could be a link in the integrated care model. Careful selection of patients, nutritional monitoring, and dietary counseling are required.

Metabolic effects of two low protein diets in chronic kidney disease stage 4-5--a randomized controlled trial

Nephrology Dialysis Transplantation, 2007

Background. International guidelines have not reached a complete agreement about the optimal amount of dietary proteins in chronic kidney disease(CKD). The aim of this study was to compare, with a randomizedcontrolled design, the metabolic effects of two diets with different protein content (0.55 vs 0.80 g/kg/day) in patients with CKD stages 4-5. Methods. Study design and sample size calculations were based on previously published experience of our group with low protein diet. The primary outcome of the study was the modification of serum urea nitrogen concentration. From 423 patients randomly assigned to the two diets 392 were analysed: 200 for the 0.55-Group and 192 for the 0.8-Group. The follow-up ranged 6-18 months. Results. Mean age was 61AE18 years, 44% were women, mean eGFR was 18AE7 ml/min/month. Three months after the dietary assignment and throughout the study period the two groups had a significantly different protein intake (0.72 vs 0.92 g/kg/day). The intentionto-treat analysis did not show any difference between the two groups. Compliance to the two test diets was significantly different (P < 0.05): 27% in the 0.55-Group and 53% in the 0.8-Group, with male gender and protein content (0.8 g/kg/day) predicting adherence to the assigned diet. The per protocol analysis, conversely, showed that serum urea nitrogen, similar at the time of randomization, significantly increased in the 0.8-Group vs 0.55-Group by 15% (P < 0.05). Serum phosphate, PTH and bicarbonate resulted similar in the two groups throughout the study. The 24 h urinary urea nitrogen significantly decreased after the first 3 months in 0.55-Group (P < 0.05), as well as the excretion of creatinine, sodium and phosphate (P < 0.05 vs baseline) and were significantly lower than the 0.8-Group. The prescription of phosphate binders, allopurinol, bicarbonate supplements and diuretics resulted significantly less frequent in the 0.55-Group (P < 0.05).

Optimizing Nutrition in Renal Patients: Effects of a Low-Protein Diet Supplemented With Ketoacids

Cureus

Background Chronic kidney disease (CKD) is a non-communicable disease; it is a major cause of morbidity and mortality in Nigeria as the incidence has been increasing in Nigeria over the last few years. A low-protein diet supplemented with ketoacids has been duly documented to reduce the malnutrition associated with CKD as well as improve estimated glomeruli filtration rate while delaying the onset of dialysis in predialysis CKD patients. Objective The aim of this study was to determine the effects of a low-protein diet supplemented with ketoacids compared to a conventional low protein on nutritional indices in predialysis CKD patients. Methods and materials A randomized controlled trial with a total of 60 participants was conducted at Delta State University Teaching Hospital (DELSUTH), Oghara, Nigeria. Participants were patients older than 18 years with CKD stage 3-5 who were not on dialysis. They were recruited and randomized into the intervention group (lowprotein diet supplemented with ketoacids) with 30 participants and the non-intervention group (low protein with placebo) with 30 participants. The mean outcome was changed in the nutritional indices from baseline till the end of the study. Results A total of 60 patients were randomly allocated to receive a low-protein diet supplemented with ketoacids (n=30) or control (n=30). All participants were included in the analysis of all outcomes. The mean change score in serum total protein, albumin, and triglycerides between the intervention and non-intervention groups were 1.1±1.1 g/dL vs 0.1±1.1 g/dL (p<0.001), 0.2±0.9 g/dL vs-0.3±0.8 g/dL (p<0.001), and 3.0±3.5 g/dL vs 1.8±3.7 g/dL, respectively. Conclusion and recommendation The use of low-protein diet supplemented with ketoacids improved the anthropometric and nutritional indices in patients with stage 3-5 CKD.

Which low-protein diet for which ckd patient? An observational, personalized approach

Nutrition, 2014

Background. Low protein diets (LPDs) are milestones in chronic kidney disease (CKD). Concerns over compliance and safety limit their use. The study was aimed at testing feasibility and main results of a multiple-choice approach to LPDs, adapted to patients' preferences. Patients and Methods In December 2007-2012, all CKD patients (stages 4-5; progressive stage 3) without contraindications (malnutrition, short life expectancy), were offered two main LPDs (proteins: 0.6 g/Kg/day): vegan supplemented (LPD-KA) or with "aproteic" commercial food (LPD-ACF). LPDs followed a qualitative approach, based upon forbidden and allowed food; 1-3 free meals/week, and flexible control policy (1-3 months). Start of dialysis, death and combined outcome (death-dialysis) were analyzed by Kaplan-Meier curves and Cox model. Comparison with dialysis in patients with GRF<15 mL/min, (corresponding to "early" dialysis start) employed standardized mortality rates, with respect to the Italian and the United States Dialysis Registry (USRDS). Results: 185 patients (222 patient-years) started at least a trial of LPD-KA, 122 (177 patients-years) LPD-ACF; only 6 patients with GFR<30 mL/min denied a LPD trial. Patients who choose LPD-KA were younger than those on LPD-ACF (63 vs 74 years) had less comorbidity (82% vs 93%), higher proteinuria (1.4 vs 0.7 g/day) and lower GFR (17 vs 23 mL/min) (p<0.001). Median protein intake was 0.7 g/Kg/day on both diets (Maroni-Mitch formula). The combined outcome (death or dialysis) was not influenced by the diet chosen (Cox analysis). Relative risk of death on the diet was 0.5 with respect to the Italian Registry and 0.3 to the USRDS. The diets had comparable costs (1 year on dialysis: 50 patient-years on LPD). Conclusions. The choice of the diet is strictly linked to patients' characteristics, thus supporting a multiple-choice offer. Once corrected for baseline data, both LPDs led to similar results, suggesting at least survival equivalence with dialysis, at lesser cost.

The risks and benefits of a low protein–essential amino acid–keto acid diet

Kidney International, 1986

The risks and benefits of a low protein-essential amino acid-keto acid diet. Twelve patients with progressive renal failure were placed on a very low protein diet supplemented by an essential amino acid-keto acid mixture for six to twelve months. Total daily intake was 0.04 g nitrogen/kg and 50 kcal/kg. Eight subjects had a significant change in the slope of reciprocal plasma creatinine, becoming less steep and in two cases positive. GFR did not improve, but in four patients the decline over twelve months was less than 0.5 muter/mm. There were significant falls in blood and urinary urea, serum phosphate P'FH and calcium X phosphate product. Body wt decreased during the first three months. Arm muscle circumference fell by 0.9 cm (P < 0.005). Serum albumin and transferrin levels did not change significantly. Muscle mass and plasma creatinine fell simultaneously in several patients. Creatinine excretion per kg muscle mass, assessed anthropometrically, declined by 21% in the first three months. This diet may slow the decline in renal function in a proportion of patients. However, muscle mass can be lost. Serum protein levels do not accurately reflect nutritional changes. A fall in plasma creatinine may not be due to improved GFR but instead to altered creatinine metabolism. Low protein diets have been used for many years for symptomatic relief of uremic symptoms. In an attempt to improve the uremic state various combinations of essential amino acids and their keto acid analogues (EAA/KAA) have been given as supplements to diets low in nitrogen [1-5]. Recently it has been claimed that low protein diets may slow the progression of renal failure [6, 7]. The evidence for a protective effect of a low protein intake is striking in experimental renal failure produced in rats by subtotal nephrectomy [8] or glomerulonephritis [9]. A number of reports have appeared which suggest there may be a similar effect in man [10-14] but to date there has been only one attempt at a prospective randomly allocated trial in human renal disease [15]. Barsotti et al [16] reported that a very low protein diet supplemented by an essential amino acid/keto acid mixture appeared to slow or in some cases completely halt the progression of advanced renal failure. If decline in renal function can indeed be arrested by such regimes, they would prove to be of enormous importance in both human and economic terms. The results of Barsotti et al were sufficiently striking to demand