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

Alexandria University

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Other: low protein diet; Drug: essential amino acids and keto-analogues supplementation

Study type: Observational

Funder types: Other

Identifiers

NCT05952544

effect of EAA/KA on GFR in CKD

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CKD stages (G2 to G4), aged ≥ 18 years old

Exclusion criteria

1. Active malignancy
2. Protein energy wasting
3. Advanced organ disease
4. pregnancy

Trial design

400 participants in 2 patient groups

control group

Description:

include patients who were on low protein diet only

Treatment:

Other: low protein diet

interventional group

Description:

include patients who consumed KA/EAA plus very low protein diet

Treatment:

Drug: essential amino acids and keto-analogues supplementation