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Supplemented Very Low Protein Diet (sVLPD) in Patients with Advanced Chronic Renal Failure: Clinical and Economic Benefits.

ABSTRACT: The supplemented very low-protein diet (sVLPD) has proven effective in slowing the progression of stage 5 chronic renal failure and postponing the start of the dialysis treatment. However, sVLPD could expose the patient to the risk of malnutrition. This diet is also difficult to implement due to the required intake of large number of keto-analogue/amino acid tablets. In our Center, the Department of Nephrology and Dialysis of Azienda Sanitaria Territoriale n 1, Pesaro-Urbino, of Italy, respecting the guidelines of normal clinical practice, we prescribed sVLPD (0.3 g/prot/day) supplemented with only essential amino acids without the use of ketoanalogues in stage 5 patients and verified its efficacy, safety and clinical and economic effects. Over the 24 months period of observation the progression of chronic kidney disease (CKD) slowed down (mean eGFR 11.6 ± 3.3 vs. 9.3 ± 2.7 mL/min/1.73 m², p < 0.001) and the start of the dialysis treatment (adjusted HR = 0.361, CI 0.200-0.650, p = 0.001) was delayed without evidence of malnutrition, in compliant vs. non-compliant patients. This led to a substantial cost reduction for the National Health System. This non-interventional longitudinal observational study is part of standard clinical practice and suggests that VLPD supplemented with essential amino acids could be extensively used to reduce the incidence of dialysis treatments, with a favorable economic impact on the NHS.

SUBMITTER: Cecchi S

PROVIDER: S-EPMC10457928 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Supplemented Very Low Protein Diet (sVLPD) in Patients with Advanced Chronic Renal Failure: Clinical and Economic Benefits.

Cecchi Sofia S Di Stante Silvio S Belcastro Sara S Bertuzzi Veronica V Cardillo Assunta A Diotallevi Laura L Grabocka Xhensila X Kulurianu Hrissa H Martello Mauro M Nastasi Valentina V Paci Della Costanza Osmy O Pizzolante Francesca F Di Luca Marina M

Nutrients 20230813 16

The supplemented very low-protein diet (sVLPD) has proven effective in slowing the progression of stage 5 chronic renal failure and postponing the start of the dialysis treatment. However, sVLPD could expose the patient to the risk of malnutrition. This diet is also difficult to implement due to the required intake of large number of keto-analogue/amino acid tablets. In our Center, the Department of Nephrology and Dialysis of Azienda Sanitaria Territoriale n 1, Pesaro-Urbino, of Italy, respectin ...[more]

PMID: 37630758

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Project description:IntroductionWeight-loss strategies through meal replacements are effective and sustainable options. However, few studies have assessed their effects on weight loss including body composition through protein-supplemented meal replacements targeting the Asian population, including Koreans. This study aimed to assess the effectiveness and safety of a protein-supplemented very-low-calorie diet (PSVLCD) for weight reduction and changes in body composition in individuals with obesity over a 12-month long-term period.MethodsIn total, 106 participants with obesity were randomly assigned to a PSVLCD or control group (food-based calorie-restricted diet). Body weight, waist circumference, body composition, and blood marker levels were measured throughout the study. Statistical analyses were performed to compare outcomes between the groups.ResultsAmong the 106 participants, 84 completed the 12-month follow-up. Intention-to-treat analysis showed that the mean weight loss from baseline to 12 months was -6.86 kg (8.21% of baseline weight) in the PSVLCD group and - 4.66 kg (5.47% of initial body weight) in the control group; the difference was -2.20 kg with a marginally significant interval (95% confidence interval [CI], -4.90; 0.50). Waist circumference (-8.35 cm vs. -4.85 cm; mean difference, -3.49 cm; 95% CI, -6.48 to -0.50) and visceral fat area (-28.28 cm2 vs. -13.26 cm2; mean difference, -15.03cm2; 95% CI, -29.01 to -1.04) also significantly decreased in the PSVLCD group at 12 months.DiscussionThe PSVLCD group demonstrated a substantial initial reduction in waist circumference that was sustained over the study period, alongside a marginally significant decrease in weight. These findings suggest that a protein-supplemented very-low-calorie diet may be an effective strategy for long-term weight management and body composition improvement in individuals with obesity.Clinical trial registrationClinicalTrials.gov, identififer NCT04597788.

Project description:Metabolic acidosis is a common complication of chronic kidney disease; current guidelines recommend treatment with alkali if bicarbonate levels are lower than 22 mMol/L. In fact, recent studies have shown that an early administration of alkali reduces progression of CKD. The aim of the study is to evaluate the effect of fruit and vegetables to reduce the acid load in CKD. We conducted a case-control study in 146 patients who received sodium bicarbonate. Of these, 54 patients assumed very low-protein diet (VLPD) and 92 were controls (ratio 1:2). We calculated every three months the potential renal acid load (PRAL) and the net endogenous acid production (NEAP), inversely correlated with serum bicarbonate levels and representing the non-volatile acid load derived from nutrition. Un-paired T-test and Chi-square test were used to assess differences between study groups at baseline and study completion. Two-tailed probability values ≤0.05 were considered statistically significant. At baseline, there were no statistical differences between the two groups regarding systolic blood pressure (SBP), diastolic blood pressure (DBP), protein and phosphate intake, urinary sodium, potassium, phosphate and urea nitrogen, NEAP, and PRAL. VLPD patients showed at 6 and 12 months a significant reduction of SBP (p < 0.0001), DBP (p < 0.001), plasma urea (p < 0.0001) protein intake (p < 0.0001), calcemia (p < 0.0001), phosphatemia (p < 0.0001), phosphate intake (p < 0.0001), urinary sodium (p < 0.0001), urinary potassium (p < 0.002), and urinary phosphate (p < 0.0001). NEAP and PRAL were significantly reduced in VLPD during follow-up. VLPD reduces intake of acids; nutritional therapy of CKD, that has always taken into consideration a lower protein, salt, and phosphate intake, should be adopted to correct metabolic acidosis, an important target in the treatment of CKD patients. We provide useful indications regarding acid load of food and drinks-the "acid load dietary traffic light".

Dataset Information

Supplemented Very Low Protein Diet (sVLPD) in Patients with Advanced Chronic Renal Failure: Clinical and Economic Benefits.

Publications

Supplemented Very Low Protein Diet (sVLPD) in Patients with Advanced Chronic Renal Failure: Clinical and Economic Benefits.

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