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

Ochsner Health System

Status: Completed

Conditions: End-Stage Renal Disease; Malnutrition

Treatments: Dietary Supplement: Plant based high protein food items

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02360748

Pro00011136

Details and patient eligibility

About

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 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

Enrollment: 8 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

single

Experimental group

Description:

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

Treatment:

Dietary Supplement: Plant based high protein food items