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

NCT05952544 | Completed

• 1 other identifier: effect of EAA/KA on GFR in CKD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases

Keywords

protein restriction; essential amino acids; ketoanalogues; GFR; CKD

Outcome Measures

Primary Outcomes (1)

• GFR decline

  effect on GFR change at one year from baseline in CKD patients

  24 months

Secondary Outcomes (2)

• effect on albumin

  24 months

• effect on calcium

  24 months

Study Arms (2)

control group

include patients who were on low protein diet only

Other: low protein diet

interventional group

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

Drug: essential amino acids and keto-analogues supplementation

Interventions

essential amino acids and keto-analogues supplementation DRUG

very low protein diet plus essential amino acids and keto-analogues supplementation

interventional group

low protein diet OTHER

patients were on low protein diet only

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• Active malignancy
• Protein energy wasting
• Advanced organ disease
• pregnancy

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (4)

• 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.

  PMID: 15354199 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.

  PMID: 21248717 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.

  PMID: 26620578 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.

  PMID: 18950911 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Amino Acids, Essential; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 19, 2023
• Study Start: July 20, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

EG (1)