Impact of Oral Protein on Nutritional Status and Quality of Life in HD Patients

Hemodialysis Complication Clinical Trial

Official title:

The Impact of Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952570
• Other study ID #: oral protein in HD
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Alexandria University
• Contact: Mohamed Mamdouh Elsayed, MD
• Phone: 00201068055103
• Email: dr_mohamedmamdouh87[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult hemodialysis patients (=18 years of age).

• Received dialysis for at least 6 months prior to study screening.

• Receive hemodialysis at least 3 times per week .

Exclusion Criteria:

• Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .

• Participants with an allergy to any ingredients in the nutritional supplements.

• Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months).

• Significant edema and fluid overload.

• Hepatic patients

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

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

Other:
• routine nutrition regimen
50 patients will receive a routine nutrition regimen for 3 months. (control group)

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Aexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on nutritional status	assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)	3 months
Primary	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
Secondary	effect on BMI	BMI assessment change at 3 months from baseline	3 months
Secondary	mid arm circumference and triceps skin fold	Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline	3 months
Secondary	dialysis adequacy	Estimation of Kt/V change at 3 months from baseline	3 months
Secondary	effect on serum albumin	measurement of serum albumin change at 3 months from baseline	3 months