Skip to content

Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05953636
Enrollment
120
Registered
2023-07-20
Start date
2023-11-01
Completion date
2024-05-01
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Supplementation

Keywords

Timing, Protein Supplementation, hemodialysis

Brief summary

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes 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. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life. 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. It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.

Interventions

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

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 )

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. * Significant edema and fluid overload. * Hepatic patients.

Design outcomes

Primary

MeasureTime frameDescription
effect on nutritional status6 weeksassessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)
effect on blood pressure6 weekssystolic and diastolic Blood pressure change at 6 weeks from baseline
effect on dialysis adequacy6 weeksEstimation of Kt/V change at 6 weeks from baseline

Secondary

MeasureTime frameDescription
effect on BMI6 weeksBMI assessment change at 6 weeks from baseline
effect on serum albumin6 weeks• serum albumin change at 6 weeks from baseline

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026