Protein Supplementation in Dialysis Patients

Study Overview
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Brief Summary
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The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.

Official Title
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Protein Supplementation in Dialysis Patients

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Dietary Supplement: Pro-Stat


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program. Adequately dialyzed (Kt/V > 1.2). Age 18-75 Exclusion criteria: Pregnant women. Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included. Patients hospitalized within the last month prior to the study. Patients with malfunctioning arterial-venous access [recirculation and/or blood flow < 500 ml/min for an arterial-venous graft (AVG) or <400 ml/min for an arterial-venous fistula (AVF)] Patients receiving steroids and/or other immunosuppressive agents.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>30 ml per serving | Dietary Supplement: Pro-Stat<br>* two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session<br>|
| Active Comparator: 2<br>60 ml per serving | Dietary Supplement: Pro-Stat<br>* two separate oral ingestions of nutrition supplement (either 30 ml per serving or at 60 ml per serving) during the hemodialysis session<br>|
| No Intervention: 3<br>chronic hemodialysis patients | |
| No Intervention: 4<br>healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| net muscle protein balance |  | 10 hours |