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

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

Detailed Description
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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.

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

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Drug: essential amino acids and keto-analogues supplementation
* Other: low protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with CKD stages (G2 to G4), aged ≥ 18 years old Exclusion Criteria: Active malignancy Protein energy wasting Advanced organ disease pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>include patients who were on low protein diet only | Other: low protein diet<br>* patients were on low protein diet only<br>|
| interventional group<br>include patients who consumed KA/EAA plus very low protein diet | Drug: essential amino acids and keto-analogues supplementation<br>* very low protein diet plus essential amino acids and keto-analogues supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR decline | effect on GFR change at one year from baseline in CKD patients | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on albumin | measurement of albumin change at one year from baseline | one year | 
| effect on calcium | measurement of calcium change at one year from baseline | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein restriction, essential amino acids, ketoanalogues, GFR, CKD