Impact of Oral Protein on Nutritional Status and Quality of Life in HD Patients
Study Details
Study Description
Brief Summary
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: protein supplement 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 3 months |
Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)
50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 3 months
|
| Placebo Comparator: control 50 patients will receive a routine nutrition regimen for 3 months. (control group) |
Other: routine nutrition regimen
50 patients will receive a routine nutrition regimen for 3 months. (control group)
|
Outcome Measures
Primary Outcome Measures
- effect on nutritional status [3 months]
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
- effect on quality of life [3 months]
assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
Secondary Outcome Measures
- effect on BMI [3 months]
BMI assessment change at 3 months from baseline
- mid arm circumference and triceps skin fold [3 months]
Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline
- dialysis adequacy [3 months]
Estimation of Kt/V change at 3 months from baseline
- effect on serum albumin [3 months]
measurement of serum albumin change at 3 months from baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult hemodialysis patients (≥18 years of age).
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Received dialysis for at least 6 months prior to study screening.
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Receive hemodialysis at least 3 times per week .
Exclusion Criteria:
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Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
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Participants with an allergy to any ingredients in the nutritional supplements.
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Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).
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Significant edema and fluid overload.
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Hepatic patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine, Aexandria University | Alexandria | Egypt | 21526 |
Sponsors and Collaborators
- Alexandria University
Investigators
- Study Chair: Mohamed Mamdouh Elsayed, MD, lecturer
- Study Chair: Amr El Kazaz, MBBCh, resident
- Study Chair: Eman E EL Gohary, MD, Professor
- Principal Investigator: Mohamed M Abdel Kader, MD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- oral protein in HD