Abstract

Recent studies emphasized the role of low-protein diets (LPDs) in the management of chronic kidney disease (CKD) in order to postpone renal replacement therapy. However, the risk of malnutrition in CKD patients on LPDs has often been debated. We present the results of a large single-center, focusing on the safety of LPDs in both diabetic and non-diabetic patients with CKD. A prospective, randomized, controlled study with 207 non-diabetic patients with CKD stage 4+ were grouped by the type of nutritional intervention - vegetarian very low protein diet with 0.3g/kg-day supplemented with ketoanalogues of essential aminoacids (sVLPD) versus LPD with 0.6g/kg-day for 15 months. We present the safety parameters at the end of study (EOS), but also after 10 years of follow-up. Safety data from a second interventional study, including 97 diabetic patients with stage 4+ CKD who received LPD supplemented with ketoanalogues of essential aminoacids (sLPD) for 12 months are also presented. Subjective Global Assessment (SGA), clinical data (Body Mass Index, BMI), and biochemical parameters (serum albumin, C-reactive protein) were analyzed. Patients’ adherence to the type of nutritional intervention was assessed by the estimated protein intake using urinary urea excretion. Both protein and energy intake were also evaluated through food diary. Nutritional status of non-diabetic patients was preserved for both sVLPD and LPD at 15 months after inclusion (SGA A 84 versus 85%, p=0.83). Moreover, the subjects continued the nutritional intervention after the EOS. After 10 years of nutritional intervention, the kidney’s survival (86 versus 46%, p<0.0001) and patients’ survival (89 versus 60%, p<0.0001) were much better in the sVLPD group. The levels of serum albumin were constantly around 4 g/dL, without any significant differences between groups at all study moments. The C-reactive protein levels were lower in patients on sVLPD at 15 months after inclusion (4 versus 5 mg/L, p<0.0001), respectively at 10 years after inclusion (5 versus 10 mg/L, p<0.0001). Patients’ adherence was confirmed at all study moments. For diabetic patients, during the study, there were improvements in body weight (BMI 27.1 versus 26.0 kg/m², p<0.0001), serum albumin (3.9 to 4.1 g/dL, p<0.0001), and in C-reactive protein levels (14 to 9 mg/L, p<0.0001). All patients had SGA A throughout the study. Nutritional intervention with different low-protein regimens seem to be safe for patients with CKD, both in diabetics and in non-diabetics.

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