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

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

Detailed Description
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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.

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

Conditions
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Hemodialysis Complication

Intervention / Treatment
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* Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)
* Other: routine nutrition regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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) for 3 months. Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protein supplement<br>50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 3 months | Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)<br>* 50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 3 months<br>|
| Placebo Comparator: control<br>50 patients will receive a routine nutrition regimen for 3 months. (control group) | Other: routine nutrition regimen<br>* 50 patients will receive a routine nutrition regimen for 3 months. (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on BMI | BMI assessment change at 3 months from baseline | 3 months | 
| mid arm circumference and triceps skin fold | Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline | 3 months | 
| dialysis adequacy | Estimation of Kt/V change at 3 months from baseline | 3 months | 
| effect on serum albumin | measurement of serum albumin change at 3 months from baseline | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral protein, Protein Supplementation, Hemodialysis, quality of life