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The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD .
Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| protein supplement | Experimental | 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months |
|
| control | Placebo Comparator | 50 patients will receive a routine nutrition regimen for 3 months. (control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral protein nutritional supplement (Fresubin protein powder) | Dietary Supplement | 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| effect on nutritional status | assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA) | 3 months |
| effect on quality of life | assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| effect on BMI | BMI assessment change at 3 months from baseline | 3 months |
| mid arm circumference and triceps skin fold | Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Mamdouh Elsayed, MD | lecturer | Study Chair |
| Amr El Kazaz, MBBCh | resident | Study Chair |
| Eman E EL Gohary, MD | Professor | Study Chair |
| Mohamed M Abdel Kader, MD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Aexandria University | Alexandria | 21526 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14582032 | Background | Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016. | |
| 21178976 | Background | Carrero JJ, Nakashima A, Qureshi AR, Lindholm B, Heimburger O, Barany P, Stenvinkel P. Protein-energy wasting modifies the association of ghrelin with inflammation, leptin, and mortality in hemodialysis patients. Kidney Int. 2011 Apr;79(7):749-56. doi: 10.1038/ki.2010.487. Epub 2010 Dec 22. |
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This research is a randomized multi-center clinical trial in which 100 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1.
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| routine nutrition regimen | Other | 50 patients will receive a routine nutrition regimen for 3 months. (control group) |
|
| 3 months |
| dialysis adequacy | Estimation of Kt/V change at 3 months from baseline | 3 months |
| effect on serum albumin | measurement of serum albumin change at 3 months from baseline | 3 months |
| 22406122 | Background | Chan M, Kelly J, Batterham M, Tapsell L. Malnutrition (subjective global assessment) scores and serum albumin levels, but not body mass index values, at initiation of dialysis are independent predictors of mortality: a 10-year clinical cohort study. J Ren Nutr. 2012 Nov;22(6):547-57. doi: 10.1053/j.jrn.2011.11.002. Epub 2012 Mar 9. |
| 18535370 | Background | Ho LC, Wang HH, Peng YS, Chiang CK, Huang JW, Hung KY, Hu FC, Wu KD. Clinical utility of malnutrition-inflammation score in maintenance hemodialysis patients: focus on identifying the best cut-off point. Am J Nephrol. 2008;28(5):840-6. doi: 10.1159/000137684. Epub 2008 Jun 6. |
| 2242761 | Background | Forquet F, Calin V, Trescol-Biemont MC, Kanellopoulos J, Mottez E, Kourilsky P, Rabourdin-Combe C, Gerlier D. Generation of hen egg lysozyme-specific and major histocompatibility complex class I-restricted cytolytic T lymphocytes: recognition of cytosolic and secreted antigen expressed by transfected cells. Eur J Immunol. 1990 Oct;20(10):2325-32. doi: 10.1002/eji.1830201023. |
| 40011815 | Derived | Elsayed MM, Abdelkader MM, ElKazaz AM, Elgohary IE. The impact of predialytic oral protein-based supplements on nutritional status and quality of life in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2025 Feb 26;26(1):103. doi: 10.1186/s12882-025-03999-3. |