Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

Study Overview
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Brief Summary
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The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes 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. 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.

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

Conditions
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Protein Supplementation

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


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. 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 75 hemodialysis patients will be randomly assigned to one of the study groups. Group A: 25 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 6 weeks 1 hour before the start of the session (pre-dialytic). Group B: 25 patients will receive oral protein nutritional supplement (ONS) for 6 weeks 2 hours after the start of the session (intra-dialytic). Group C: 25 patients will receive oral protein nutritional supplement (ONS) for 6 weeks in non-dialysis days (inter-dialytic).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pre-dialytic<br>25 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 6 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)<br>* 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 )<br>|
| Other: intra-dialytic<br>25 patients will receive oral protein nutritional supplement (ONS) for 6 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)<br>* 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 )<br>|
| Other: inter-dialytic<br>25 patients will receive oral protein nutritional supplement (ONS) for 6 weeks in non-dialysis days (inter-dialytic). | Dietary Supplement: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)<br>* 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 )<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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect on BMI | BMI assessment change at 6 weeks from baseline | 6 weeks | 
| effect on serum albumin | • serum albumin change at 6 weeks from baseline | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Timing, Protein Supplementation, hemodialysis