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

Primary Purpose

End-Stage Renal Disease, Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Plant based high protein food items
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OCHSNER
  • Davita

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single

Arm Description

Pilot Study in which patients will be adding food items to improve their nutritional status

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Phosphorous measurements will be followed during the course of the study and on completion
Hyperphosphatemia will improve on plant based high protein diet
Obesity
On this intervention we will follow patients' weight as a secondary outcome in obese patients

Full Information

First Posted
February 3, 2015
Last Updated
April 12, 2018
Sponsor
Ochsner Health System
Collaborators
Fresenius Medical Care North America, DaVita Dialysis, Food Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02360748
Brief Title
A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients
Acronym
PBPD
Official Title
A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ochsner Health System
Collaborators
Fresenius Medical Care North America, DaVita Dialysis, Food Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single
Arm Type
Experimental
Arm Description
Pilot Study in which patients will be adding food items to improve their nutritional status
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant based high protein food items
Intervention Description
Patients will add high protein plant based food items to their diet
Primary Outcome Measure Information:
Title
Nutritional Parameters, bone and mineral metabolism
Description
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
Time Frame
one month
Secondary Outcome Measure Information:
Title
Phosphorous measurements will be followed during the course of the study and on completion
Description
Hyperphosphatemia will improve on plant based high protein diet
Time Frame
one month
Title
Obesity
Description
On this intervention we will follow patients' weight as a secondary outcome in obese patients
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
OCHSNER
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Davita
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will upload results
Citations:
PubMed Identifier
20093346
Citation
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.
Results Reference
background
PubMed Identifier
20404416
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.
Results Reference
background
PubMed Identifier
20185606
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. Epub 2010 Feb 25.
Results Reference
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A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients

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