Malnutrition Clinical Trial
— PBPDOfficial title:
A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients
Verified date | April 2018 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 15, 2017 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - ESRD Patients on dialysis with an albumin of <4.0 with the ability to consent and willingness to enroll in the study Exclusion Criteria: - Other exclusions include - liver cirrhosis, - cardiac cirrhosis, - dysphagia due to an old Cerebrovascular accident / muscular dystrophy, - Hyperkalemia (>5.5) |
Country | Name | City | State |
---|---|---|---|
United States | Davita | Baton Rouge | Louisiana |
United States | OCHSNER | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Ochsner Health System | DaVita Dialysis, Food Care, Inc., Fresenius Medical Care North America |
United States,
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Obesity | On this intervention we will follow patients' weight as a secondary outcome in obese patients | one month |
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