Effect of essential amino acid кetoanalogues and protein restriction diet on morphogenetic proteins (FGF-23 and Кlotho) in 3b-4 stages chronic кidney disease patients: a randomized pilot study.
Study Goal
The researchers aimed to compare the effects of a low-protein diet (LPD) with and without essential amino acid ketoanalogue supplementation (KA) on serum Klotho, FGF-23 levels, and cardiovascular parameters in CKD patients.
Results Summary
The LPD + KA group showed improved FGF-23 and Klotho levels, reduced cardiovascular calcification, and better nutritional status compared to LPD alone, which was associated with increased malnutrition risk and adverse cardiovascular changes.
Population
Non-diabetic CKD patients (stages 3b-4), compliant with LPD (0.6 g/kg/day).
Effective Dosage
0.6 g/kg of body weight/day (LPD).
Duration
14 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low protein diet (LPD) alone | decrease | body mass indices | non-diabetic CKD 3b-4 stage patients | p=0.046 | decrease | #1 |
low protein diet (LPD) alone | decrease | muscle body mass | men | p=0.027 | decrease | #2 |
low protein diet (LPD) alone | decrease | muscle body mass | woman | p=0.044 | decrease | #3 |
low protein diet (LPD) with essential amino acid ketoanalogue supplementation (KA) | decrease | FGF-23 | non-diabetic CKD 3b-4 stage patients | p=0.029 | lower | #4 |
low protein diet (LPD) with essential amino acid ketoanalogue supplementation (KA) | increase | sKlotho | non-diabetic CKD 3b-4 stage patients | p=0.037 | higher | #5 |
low protein diet (LPD) alone | increase | AI (stiffness (augmentation) indices) | non-diabetic CKD 3b-4 stage patients | p=0.034 | increase | #6 |
low protein diet (LPD) alone | increase | VCS (valvular calcification score) | non-diabetic CKD 3b-4 stage patients | p=0.048 | increase | #7 |
low protein diet (LPD) alone | increase | LVMMI | non-diabetic CKD 3b-4 stage patients | p=0.023 | increase | #8 |
BACKGROUND: A low protein diet (LPD) with essential amino acid ketoanalogue supplementation (KA) may contribute in improving of chronic kidney disease (CKD), while the exact mechanisms of KA's effect are not established yet. We have conducted a prospective, randomized, controlled comparative study of LPD + KA and LPD alone in relation to serum Klotho, FGF-23 levels in CKD patients. METHODS: 79 non-diabetic CKD 3b-4 stage patients, compliant with LPD diet (0.6 g/kg of body weight/day), had been selected. The patients were randomized into two groups. The first group (42 patients) received LPD + КA. The second group (37 patients) continued the LРD alone. In addition to routine tests, serum Klotho, FGF-23 levels, as well as bioimpedance analysis, sphygmography (stiffness (augmentation) indices (AI), central (aortal) blood pressure) with a «SphygmaCor» device; echocardiography (valvular calcification score (VCS) and LVMMI), were performed. RESULTS: There were body mass indices' decrease (p = 0.046), including muscle body mass in men (p = 0.027) and woman (p = 0.044) in the LPD group to the end of study (14th month). In addition, lower FGF-23 (p = 0.029), and higher sKlotho (p = 0.037) were detected in the LPD + KA group compared to the LPD one. The increase in AI (p = 0.034), VCS (p = 0.048), and LVMMI (p = 0.023) was detected more often in the LPD group at the end of study. CONCLUSION: LPD + KA provides support for nutrition status and contributes to more efficient correction of FGF-23 and Klotho abnormalities that may result in cardiovascular calcification and cardiac remodeling decreasing in CKD. At the same time, a prolonged LPD alone may lead to malnutrition.