A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients

Malnutrition Clinical Trial

— PBPD  

Official title:

A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360748
• Other study ID #: Pro00011136
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: April 12, 2018
• Start date: October 2015
• Est. completion date: September 15, 2017

Study information

• Verified date: April 2018
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic
• Malnutrition

Intervention

Dietary Supplement:
• Plant based high protein food items
Patients will add high protein plant based food items to their diet

Locations

Country	Name	City	State
United States	Davita	Baton Rouge	Louisiana
United States	OCHSNER	Baton Rouge	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Ochsner Health System	DaVita Dialysis, Food Care, Inc., Fresenius Medical Care North America

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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