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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-09-15

Brief Summary

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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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Detailed Description

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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

Conditions

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End-Stage Renal Disease Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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single

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

Group Type EXPERIMENTAL

Plant based high protein food items

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Plant based high protein food items

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No