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

Not Applicable

Completed

• Conditions: Hemodialysis Complication
• Interventions: Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder); Other: routine nutrition regimen

• Registration Number: NCT05952570
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2023-07-02
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-19
• Study Start: 2023-08-01
• Primary Completion: 2024-06-15
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
effect on quality of life	3 months	assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form
effect on nutritional status	3 months	assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)

Secondary Outcome Measures

Name	Time	Method
mid arm circumference and triceps skin fold	3 months	Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline
effect on BMI	3 months	BMI assessment change at 3 months from baseline
effect on serum albumin	3 months	measurement of serum albumin change at 3 months from baseline
dialysis adequacy	3 months	Estimation of Kt/V change at 3 months from baseline

Trial Locations

Locations (1)

Faculty of Medicine, Aexandria University; 🇪🇬 Alexandria, Egypt