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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Center Hemodialysis patients |
|
| Group B | Active Comparator | Center hemodialysis patients |
|
| Group C | No Intervention | Center Hemodialysis Patients | |
| Group D | Active Comparator | Peritoneal dialysis patients |
|
| Group E | No Intervention | Peritoneal dialysis patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein Food Bar Intelligent Indulgence | Dietary Supplement | Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Schiller-Moran, MD | Satellite Healthcare, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Healthcare, Inc. | Mountain View | California | 94041 | United States | ||
| WellBound, Inc. |
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| Protein Food Bar Intelligent Indulgence | Dietary Supplement | 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 |
|
| Protein Food Bar Intelligent Indulgence | Dietary Supplement | Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar. |
|
| 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 |
| Mountain View |
| California |
| 94041 |
| United States |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D034141 | Hypoalbuminemia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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