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| ID | Type | Description | Link |
|---|---|---|---|
| AGR DTD 06-26-2019 | Other Grant/Funding Number | National Kidney Foundation | |
| OCR21882 | Other Identifier | UF ID |
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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
| National Kidney Foundation, United States | OTHER |
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The study team aims to provide a food snack that is high in protein (30 g) for two weeks each month (6 treatments per patient per month) for 6 consecutive months, post-dialysis treatment, to in-center hemodialysis patients of all vintages and with all levels and types of comorbidities. The study team will compare changes in serum albumin during the intervention (6 months) using the patients' own serum albumin results that are collected for three months prior to and three months after the intervention. Additionally, the study team will determine participants' dietary habits and appetite pre-, during and post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Food Snack | Experimental | Provide a high protein food snack the first 2 weeks of each month for 6 months. Each participant will receive an 8 ounce food snack after dialysis for a total of 6 food snacks for each month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein Food Snack | Other | The intervention is 6-months using a food snack with control being three months prior to and three months after-study invention whereby serum albumin levels will be collected monthly. If patients are participating in a supplement program, they will be maintained throughout all ten months of the study so long as the criteria for the supplement program (enrollment and discontinuation) is still being met. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum albumin | Change in grams of albumin per deciliter of blood (g/dL). Pre-, during, and 3-months post-intervention will complete monthly serum albumin lab draws. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorus | change in milligrams of phosphorus per deciliter of blood (mg/dL). Pre-, during, and 3-months post-intervention will complete monthly serum phosphorus lab draws. | Up to 12 months |
| Diet Intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette M Andrade, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresenius Medical Care | Gainesville | Florida | 32606 | United States |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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This is a 9-item survey, "Diet Intake Survey", that obtains information about participants' appetites and dietary behaviors. Pre-, during, and 3-months post-intervention will complete monthly surveys on participants' diet habits to assess the impact the food snack has on total protein to calories.
| Up to 12 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |