Clinical trial NCT05952570: Impact of Predialytic Oral Protein on Nutritional Status and Quality of Life in HD Patients
Official title: The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Keywords: oral protein
Protein Supplementation
Hemodialysis
quality of life
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

* Group A: 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.
* Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: effect on nutritional status
timeFrame: 3 months
measure: effect on quality of life
timeFrame: 3 months
Secondary outcomes:
measure: effect on BMI
timeFrame: 3 months
measure: mid arm circumference and triceps skin fold
timeFrame: 3 months
measure: dialysis adequacy
timeFrame: 3 months
measure: effect on serum albumin
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Aexandria University
Study officials:
affiliation: lecturer
name: Mohamed Mamdouh Elsayed, MD
role: STUDY_CHAIR
affiliation: resident
name: Amr El Kazaz, MBBCh
role: STUDY_CHAIR
affiliation: Professor
name: Eman E EL Gohary, MD
role: STUDY_CHAIR
affiliation: Professor
name: Mohamed M Abdel Kader, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.