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Completed

NCT Number: NCT02360748

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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Davita, Baton Rouge, Louisiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Plant based high protein food items

Dietary Supplement

Patients will add high protein plant based food items to their diet

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Obesity

    Time frame: one month

    On this intervention we will follow patients' weight as a secondary outcome in obese patients

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • DaVita, Inc.
  • Food Care, Inc.
  • Fresenius Medical Care North America

Registry information

Official study title

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

Acronym: PBPD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2015
Registry last updated
Apr 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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