Clinical trial NCT02360748: A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients
Official title: A Plant Based High Protein Diet to Improve Nutritional Outcomes in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Malnutrition
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care North America
name: DaVita Dialysis
name: Food Care, Inc.
First posted: 2015-02-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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)

Primary outcomes:
measure: Nutritional Parameters, bone and mineral metabolism
timeFrame: one month
Secondary outcomes:
measure: Phosphorous measurements will be followed during the course of the study and on completion
timeFrame: one month
measure: Obesity
timeFrame: one month
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: OCHSNER
state: Louisiana
city: Baton Rouge
country: United States
facility: Davita
state: Louisiana
Study officials:
References:
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.
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.
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.