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

Not Applicable

Completed

• Conditions: End-Stage Renal Disease; Malnutrition
• Interventions: Dietary Supplement: Plant based high protein food items

• Registration Number: NCT02360748
• Lead Sponsor: Ochsner Health System

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

Study Timeline

• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Study Start: 2015-10
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single	Plant based high protein food items	Pilot Study in which patients will be adding food items to improve their nutritional status

Primary Outcome Measures

Name	Time	Method
Nutritional Parameters, bone and mineral metabolism	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 Outcome Measures

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

Trial Locations

Locations (2)

OCHSNER; 🇺🇸 Baton Rouge, Louisiana, United States

Davita; 🇺🇸 Baton Rouge, Louisiana, United States