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

NCT05952570 | Completed

• 1 other identifier: oral protein in HD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis Complication

Keywords

oral protein; Protein Supplementation; Hemodialysis; quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• effect on BMI

  3 months

• mid arm circumference and triceps skin fold

  3 months

• dialysis adequacy

  3 months

• effect on serum albumin

  3 months

Study Arms (2)

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

Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)

control

PLACEBO COMPARATOR

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

Other: routine nutrition regimen

Interventions

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

protein supplement

routine nutrition regimen OTHER

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

control

Eligibility Criteria

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

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (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.

  PMID: 14582032 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.

  PMID: 21178976 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.

  PMID: 22406122 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.

  PMID: 18535370 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.

  PMID: 2242761 BACKGROUND

• 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.

  PMID: 40011815 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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)

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 19, 2023
• Study Start: August 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 1, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

EG (1)