NCT05952570

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis Complication

Interventions

Type	Name	Description
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) 1 hour before the start of the session (predialytic) for 3 months
OTHER	routine nutrition regimen	50 patients will receive a routine nutrition regimen for 3 months. (control group)

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-15
• Completion: 2024-07-01
• First posted: 2023-07-19
• Last updated: 2024-07-09

Locations

1 site across 1 country: Egypt