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

Overview

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.

Full Title of Study: “A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2017

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: single
    • Pilot Study in which patients will be adding food items to improve their nutritional status

Clinical Trial Outcome Measures

Primary Measures

  • Nutritional Parameters, bone and mineral metabolism
    • Time Frame: one month
    • 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 Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ochsner Health System
  • Collaborator
    • Fresenius Medical Care North America
  • Provider of Information About this Clinical Study
    • Principal Investigator: Naseer Khan, MD, MD – Ochsner Health System

References

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.

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.

Citations Reporting on Results

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.

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