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| Name | Class |
|---|---|
| Fresenius Medical Care North America | INDUSTRY |
| DaVita, Inc. | INDUSTRY |
| Food Care, Inc. | INDUSTRY |
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The study proposes that addition of high protein plant based diet will improve serum albumin as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient will be provided additional food items to help improve their nutritional status.
The purpose of this study is to improve the albumin and nutritional status of patient with ESRD on dialysis. Serum albumin is a marker to show how well the patient's overall nutrition is. When albumin level drops it signifies poor outcome in dialysis patients both in terms of complications as well as mortality. Our goal on dialysis is to improve serum albumin level as close to normal as possible. This study intends to also improve phosphorus level by adding high protein sources which are plant based. In this study we intend to add certain plant based food items which are high in protein content. Studies have shown that these particular food items considerably increase serum albumin level but at the same time they are safe as they do not increase the phosphorous levels in kidney patients. Patients will be provided the additional food items and all their nutritional parameters will be monitored at baseline and during the study period of one month
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single | Experimental | Pilot Study in which patients will be adding food items to improve their nutritional status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based high protein food items | Dietary Supplement | Patients will add high protein plant based food items to their diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional Parameters, bone and mineral metabolism | albumin will improve on high protein plant based diet; we will measure patients' baseline nutritional parameters which will include serum album; Calcium and phosphate levels and then follow the same parameters on the dietary intervention | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphorous measurements will be followed during the course of the study and on completion | Hyperphosphatemia will improve on plant based high protein diet | one month |
| Obesity | On this intervention we will follow patients' weight as a secondary outcome in obese patients |
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Inclusion Criteria:
Exclusion Criteria:
Other exclusions include
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OCHSNER | Baton Rouge | Louisiana | 70809 | United States | ||
| Davita |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20093346 | Background | Kalantar-Zadeh K, Gutekunst L, Mehrotra R, Kovesdy CP, Bross R, Shinaberger CS, Noori N, Hirschberg R, Benner D, Nissenson AR, Kopple JD. Understanding sources of dietary phosphorus in the treatment of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Mar;5(3):519-30. doi: 10.2215/CJN.06080809. Epub 2010 Jan 21. | |
| 20404416 |
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Will upload results
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| one month |
| Baton Rouge |
| Louisiana |
| 70810 |
| United States |
| Noori N, Sims JJ, Kopple JD, Shah A, Colman S, Shinaberger CS, Bross R, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Organic and inorganic dietary phosphorus and its management in chronic kidney disease. Iran J Kidney Dis. 2010 Apr;4(2):89-100. |
| 20185606 | Result | Noori N, Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Kopple JD. Association of dietary phosphorus intake and phosphorus to protein ratio with mortality in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Apr;5(4):683-92. doi: 10.2215/CJN.08601209. Epub 2010 Feb 25. |
| 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 |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |