End-Stage Renal Disease, Malnutrition
Conditions
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
Interventions
DIETARY_SUPPLEMENTPlant based high protein food items
Patients will add high protein plant based food items to their diet
Sponsors
Fresenius Medical Care North America
DaVita, Inc.
Food Care, Inc.
Ochsner Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed