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

Study Overview
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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.

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

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

Conditions
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End-Stage Renal Disease, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Plant based high protein food items


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single<br>Pilot Study in which patients will be adding food items to improve their nutritional status | Dietary Supplement: Plant based high protein food items<br>* Patients will add high protein plant based food items to their diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional Parameters, bone and mineral metabolism | 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 | one month | 

Secondary Outcome Measures

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