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This study aims to investigate the effect of protein restriction plus KA/EAA supplementation on GFR decline in CKD patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | include patients who were on low protein diet only |
| |
| interventional group | include patients who consumed KA/EAA plus very low protein diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| essential amino acids and keto-analogues supplementation | Drug | very low protein diet plus essential amino acids and keto-analogues supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| GFR decline | effect on GFR change at one year from baseline in CKD patients | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| effect on albumin | measurement of albumin change at one year from baseline | 24 months |
| effect on calcium | measurement of calcium change at one year from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mamdouh Elsayed, MD | lecturer | Principal Investigator |
| Bassant Sabry | pharmacist | Study Chair |
| Alaa Soliman | pharmacist | Study Chair |
| Mohamed A. Mekawy | pharmacist | Study Chair |
| Engy Emam | Clinical Pharmacist | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Aexandria University | Alexandria | 21526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15354199 | Background | 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. | |
| 21248717 | Background | 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. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000601 | Amino Acids, Essential |
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
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| low protein diet | Other | patients were on low protein diet only |
|
| 24 months |
| 26620578 | Background | 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. |
| 18950911 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |