Renal Insufficiency, Chronic Clinical Trial
Official title:
Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis CKD Patients - A Randomized, Controlled, Open-labelled Clinical Trial
Supplementation of ketoanalogues of essential amino acids improves the protein quality of
protein restricted diets without burdening the kidneys. The ketoanalogues are transaminated
by aminotransferases to the corresponding amino acids by incorporating nitrogen from amino
groups derived from endogenous amino acid degradation. Therefore, less nitrogen needs to be
excreted and the kidney's workload is reduced.
The purpose of the trial is to investigate the impact of Ketosteril® supplementation on A)
nutritional safety and tolerance of a low protein diet (LPD) (0.6 g protein/kg bodyweight
(BW)/day)and B) net protein synthesis in pre-dialysis CKD patients.
Changes of urea in serum and urine will be assessed under controlled metabolic balance
conditions in non-dialysed CKD patients consuming a LPD supplemented with Ketosteril® at 1
tablet/5 kg body weight/day compared to the same, isonitrogenous and isocaloric diet without
Ketosteril®.
Changes in protein synthesis and degradation at the defined protein intake with or without
Ketosteril® supplementation will be investigated - based on nitrogen balance, normalized
protein catabolic rates as well as blood levels of defined proteins as surrogate markers for
net protein synthesis and anabolic signaling.
n/a
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