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?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Alexandria, Egypt, 21526
- Faculty of Medicine, Aexandria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
medical records of Patients with CKD stages (G2 to G4), will be retrospectively screened from December 2021 till December 2023.
Patients will be divided into two groups:
Control group who was on low protein diet only, while the other group (interventional) consumed KA/EAA plus very low protein diet.
Description
Inclusion Criteria:
- Patients with CKD stages (G2 to G4), aged ≥ 18 years old
Exclusion Criteria:
- Active malignancy
- Protein energy wasting
- Advanced organ disease
- pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
include patients who were on low protein diet only
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patients were on low protein diet only
|
|
interventional group
include patients who consumed KA/EAA plus very low protein diet
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very low protein diet plus essential amino acids and keto-analogues supplementation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GFR decline
Time Frame: 24 months
|
effect on GFR change at one year from baseline in CKD patients
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effect on albumin
Time Frame: 24 months
|
measurement of albumin change at one year from baseline
|
24 months
|
|
effect on calcium
Time Frame: 24 months
|
measurement of calcium change at one year from baseline
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Mamdouh Elsayed, MD, Lecturer
- Study Chair: Bassant Sabry, Pharmacist
- Study Chair: Alaa Soliman, Pharmacist
- Study Chair: Mohamed A. Mekawy, Pharmacist
- Study Chair: Engy Emam, Clinical Pharmacist
Publications and helpful links
General Publications
- Feiten SF, Draibe SA, Watanabe R, Duenhas MR, Baxmann AC, Nerbass FB, Cuppari L. Short-term effects of a very-low-protein diet supplemented with ketoacids in nondialyzed chronic kidney disease patients. Eur J Clin Nutr. 2005 Jan;59(1):129-36. doi: 10.1038/sj.ejcn.1602050.
- Gao X, Huang L, Grosjean F, Esposito V, Wu J, Fu L, Hu H, Tan J, He C, Gray S, Jain MK, Zheng F, Mei C. Low-protein diet supplemented with ketoacids reduces the severity of renal disease in 5/6 nephrectomized rats: a role for KLF15. Kidney Int. 2011 May;79(9):987-96. doi: 10.1038/ki.2010.539. Epub 2011 Jan 19.
- Jiang Z, Zhang X, Yang L, Li Z, Qin W. Effect of restricted protein diet supplemented with keto analogues in chronic kidney disease: a systematic review and meta-analysis. Int Urol Nephrol. 2016 Mar;48(3):409-18. doi: 10.1007/s11255-015-1170-2. Epub 2015 Nov 30.
- Menon V, Kopple JD, Wang X, Beck GJ, Collins AJ, Kusek JW, Greene T, Levey AS, Sarnak MJ. Effect of a very low-protein diet on outcomes: long-term follow-up of the Modification of Diet in Renal Disease (MDRD) Study. Am J Kidney Dis. 2009 Feb;53(2):208-17. doi: 10.1053/j.ajkd.2008.08.009. Epub 2008 Oct 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- effect of EAA/KA on GFR in CKD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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