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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 85
Population
85 patients with 3B4 stages of CKD, compliant to LPD (0.6 g of protein/kg body weight) + KA (1 tablet/5 kg body weight)
Methods
Prospective, randomized, controlled clinical study comparing LPD with substitution of animal protein with soy protein + KA vs conventional LPD + KA for 12 months
Duration
12 months
Funding
Unclear

Background

It has been established that the use of a low-protein diet (LPD) in combination with ketoanalogues (KA) of essential amino acids can contribute to cardio- and nephroprotection in chronic kidney disease (CKD). Moreover, it has been shown that replacing part of the animal protein with soy protein (SP) in the diet contributed to more pronounced nephro- and cardioprotection in CKD, however, the data, available in the literature, are mainly represented by experimental studies.

Aim

To compare the effects of 2 types of diets on the main parameters of nephro- and cardioprotection in patients with CKD.

Materials and methods

We have conducted a prospective, randomized, controlled clinical study which included 85 patients with 3B4 stages of CKD, compliant to LPD (0.6 g of protein/kg body weight) + KA (1 tablet/5 kg body weight). 43 patients (Group 1) received LPD with replacing animal protein with soy (60% soy protein + 40% another vegetable proteins) + KA, and 42 patients (control group, Group 2) received LPD (60% animal protein + 40% vegetable protein) + KA, within 12 months.

Results

The dietary substitution of animal protein with SP to a greater extent delayed the decrease in glomerular filtration rate (-5.9% vs -13.3%; p=0.048), the increase in left ventricular hypertrophy (+4.7% vs +12.3%; p=0.042), as well as the increase in central systolic blood pressure (+2.6% vs +13.0%; p=0.021), augmentation index (+7.6% vs +23.3%; p=0.010), slowed down the decrease in lean body mass in men (+0.9% vs -11.2%; p=0.017) and women (-1.8% vs -10.3%; p=0.024), increase in phosphorus (-10.3% vs +13.0%; p=0.029), cholesterol (-10.7% vs -3.4%; p=0.047) and urea (+6.3% vs +19.6%; p=0.035) serum levels.

Conclusion

The use of LPD with substitution of animal protein with soy protein + KA provides a more pronounced effect on nephro- and cardioprotection as well as maintenance of nutritional status, than conventional LPD + KA in patients with 3B4 stages of CKD.

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