Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

NCT05953636 | Completed

• 1 other identifier: Timing of protein in HD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients.

Conditions

Protein Supplementation

Keywords

Timing; Protein Supplementation; hemodialysis

Outcome Measures

Primary Outcomes (3)

• effect on nutritional status

  assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)

  6 weeks

• effect on blood pressure

  systolic and diastolic Blood pressure change at 6 weeks from baseline

  6 weeks

• effect on dialysis adequacy

  Estimation of Kt/V change at 6 weeks from baseline

  6 weeks

Secondary Outcomes (2)

• effect on BMI

  6 weeks

• effect on serum albumin

  6 weeks

Study Arms (3)

pre-dialytic

OTHER

40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic).

Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

intra-dialytic

OTHER

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic).

Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

inter-dialytic

OTHER

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).

Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)

Interventions

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) DIETARY_SUPPLEMENT

oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )

inter-dialytic; intra-dialytic; pre-dialytic

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.
• 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

• Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.

  PMID: 23698226 BACKGROUND

• Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195.

  PMID: 28633456 BACKGROUND

• Kistler BM, Benner D, Burrowes JD, Campbell KL, Fouque D, Garibotto G, Kopple JD, Kovesdy CP, Rhee CM, Steiber A, Stenvinkel P, Ter Wee P, Teta D, Wang AYM, Kalantar-Zadeh K. Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Jan;28(1):4-12. doi: 10.1053/j.jrn.2017.10.003.

  PMID: 29249295 BACKGROUND

• Elsayed MM, Elkazaz AM. The effect of different timings of protein supplementation on variable outcomes in hemodialysis patients: a randomized clinical trial. Clin Exp Nephrol. 2025 May;29(5):672-680. doi: 10.1007/s10157-025-02626-7. Epub 2025 Jan 18.

  PMID: 39826005 DERIVED

Study Officials

• Mohamed Mamdouh Elsayed, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• Amr Mohamed El Kazaz, MBBCh

  resident

  STUDY CHAIR

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 120 hemodialysis patients will be randomly assigned to one of the study groups. * Group A: 40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic). * Group B: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic). * Group C: 40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 20, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

EG (1)