Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

Study Overview
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Brief Summary
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This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.

Official Title
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Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

Conditions
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End Stage Renal Disease, Hypoalbuminemia, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Protein Food Bar Intelligent Indulgence
* Dietary Supplement: Protein Food Bar Intelligent Indulgence
* Dietary Supplement: Protein Food Bar Intelligent Indulgence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days. 18 years of age or older. Must have a reasonable expectation of remaining on treatment for at least 3 months. Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study. Must be able to understand and sign the informed consent. Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods. Exclusion Criteria: Allergy to protein, milk, nuts or wheat. Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry. Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L. Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease. Hospitalization for an infectious condition within 4 weeks prior to study entry. Planned surgery within the three month study period including planned kidney transplantation.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Center Hemodialysis patients | Dietary Supplement: Protein Food Bar Intelligent Indulgence<br>* Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months<br>|
| Active Comparator: Group B<br>Center hemodialysis patients | Dietary Supplement: Protein Food Bar Intelligent Indulgence<br>* Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days<br>|
| No Intervention: Group C<br>Center Hemodialysis Patients | |
| Active Comparator: Group D<br>Peritoneal dialysis patients | Dietary Supplement: Protein Food Bar Intelligent Indulgence<br>* Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.<br>|
| No Intervention: Group E<br>Peritoneal dialysis patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period. |  | Each month for the three months. | 
| Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate. |  | Each month for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period |  | Month 3 | 
| Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars. |  | Each month for 3 months | 
| Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored |  | Each month for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Hypoalbuminemia, Dietary Supplements, Hemodialysis, Peritoneal Dialysis