NCT05952544

Effect of Protein Restriction Plus EAA/KA Supplementation on GFR Decline in CKD

Does Protein Restriction Plus Essential Amino Acids and Keto-analogues Supplementation Have a Beneficial Effect on GFR Decline in CKD Patients?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.

Detailed description

In chronic kidney disease (CKD) patients, ketoacid analogues of essential amino acids (KA/EAA) are administered to reduce the production of harmful metabolic products and enhance nutritional status. Protein restriction combined with AA supplement may have beneficial effects on CKD in several ways, by reducing nitrogen waste, oxidative stress, and inflammation, and by protecting against hemodynamic changes in glomerular hyperfiltration. several clinical trials have documented that very low protein diets (VLPD) supplemented with KA/EAA preserve the rate of progression of advanced CKD. However, in long-term follow-up of the MDRD study, VLPD plus KA/EAA treatment did not delay progression to dialysis or transplantation. As a result, no firm conclusions have been drawn on the effectiveness of protein-restricted diets combined with KA/EAA supplements in retarding CKD progression.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	essential amino acids and keto-analogues supplementation	very low protein diet plus essential amino acids and keto-analogues supplementation
OTHER	low protein diet	patients were on low protein diet only

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-03-30
• Completion: 2024-05-15
• First posted: 2023-07-19
• Last updated: 2024-08-19

Locations

1 site across 1 country: Egypt