High-Protein Food Snack for Dialysis Patients
Primary Purpose
Renal Failure, Albumin; Double, Diet Habit
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Food Snack
Sponsored by
About this trial
This is an interventional basic science trial for Renal Failure
Eligibility Criteria
Inclusion Criteria:
- Chronic Hemodialysis (CHD) therapy
- Active and permanent patients to the area Fresenius Kidney Care (FKC) Dialysis clinic
- No food allergies or dietary restrictions
- No contraindications to consuming anything by mouth as per the medical director and/or personal reporting.
Exclusion Criteria:
- Patients unable to commit to the full time commitments of the study
- Those who have food allergies, especially to Chicken, Pork Sausage, Eggs, Fresh Cilantro, Red and yellow bell peppers, Cucumbers, Mrs. Dash Grill Seasoning, Newman's Own Ranch Salad Dressing, Minced garlic, Sweet pickle relish, Vidalia onions, tomatoes
- Dietary restrictions as medically indicated,
- Trouble chewing/swallowing as confirmed by medical director, and/or personal reporting.
Sites / Locations
- Fresenius Medical Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Protein Food Snack
Arm Description
Provide a high protein food snack the first 2 weeks of each month for 6 months. Each participant will receive an 8 ounce food snack after dialysis for a total of 6 food snacks for each month.
Outcomes
Primary Outcome Measures
Serum albumin
Change in grams of albumin per deciliter of blood (g/dL). Pre-, during, and 3-months post-intervention will complete monthly serum albumin lab draws.
Secondary Outcome Measures
Serum phosphorus
change in milligrams of phosphorus per deciliter of blood (mg/dL). Pre-, during, and 3-months post-intervention will complete monthly serum phosphorus lab draws.
Diet Intake
This is a 9-item survey, "Diet Intake Survey", that obtains information about participants' appetites and dietary behaviors. Pre-, during, and 3-months post-intervention will complete monthly surveys on participants' diet habits to assess the impact the food snack has on total protein to calories.
Full Information
NCT ID
NCT04134377
First Posted
October 16, 2019
Last Updated
August 20, 2020
Sponsor
University of Florida
Collaborators
Fresenius Medical Care North America, National Kidney Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04134377
Brief Title
High-Protein Food Snack for Dialysis Patients
Official Title
High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Fresenius Medical Care North America, National Kidney Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study team aims to provide a food snack that is high in protein (30 g) for two weeks each month (6 treatments per patient per month) for 6 consecutive months, post-dialysis treatment, to in-center hemodialysis patients of all vintages and with all levels and types of comorbidities. The study team will compare changes in serum albumin during the intervention (6 months) using the patients' own serum albumin results that are collected for three months prior to and three months after the intervention. Additionally, the study team will determine participants' dietary habits and appetite pre-, during and post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Albumin; Double, Diet Habit
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protein Food Snack
Arm Type
Experimental
Arm Description
Provide a high protein food snack the first 2 weeks of each month for 6 months. Each participant will receive an 8 ounce food snack after dialysis for a total of 6 food snacks for each month.
Intervention Type
Other
Intervention Name(s)
Protein Food Snack
Intervention Description
The intervention is 6-months using a food snack with control being three months prior to and three months after-study invention whereby serum albumin levels will be collected monthly. If patients are participating in a supplement program, they will be maintained throughout all ten months of the study so long as the criteria for the supplement program (enrollment and discontinuation) is still being met.
Primary Outcome Measure Information:
Title
Serum albumin
Description
Change in grams of albumin per deciliter of blood (g/dL). Pre-, during, and 3-months post-intervention will complete monthly serum albumin lab draws.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Serum phosphorus
Description
change in milligrams of phosphorus per deciliter of blood (mg/dL). Pre-, during, and 3-months post-intervention will complete monthly serum phosphorus lab draws.
Time Frame
Up to 12 months
Title
Diet Intake
Description
This is a 9-item survey, "Diet Intake Survey", that obtains information about participants' appetites and dietary behaviors. Pre-, during, and 3-months post-intervention will complete monthly surveys on participants' diet habits to assess the impact the food snack has on total protein to calories.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chronic Hemodialysis (CHD) therapy
Active and permanent patients to the area Fresenius Kidney Care (FKC) Dialysis clinic
No food allergies or dietary restrictions
No contraindications to consuming anything by mouth as per the medical director and/or personal reporting.
Exclusion Criteria:
Patients unable to commit to the full time commitments of the study
Those who have food allergies, especially to Chicken, Pork Sausage, Eggs, Fresh Cilantro, Red and yellow bell peppers, Cucumbers, Mrs. Dash Grill Seasoning, Newman's Own Ranch Salad Dressing, Minced garlic, Sweet pickle relish, Vidalia onions, tomatoes
Dietary restrictions as medically indicated,
Trouble chewing/swallowing as confirmed by medical director, and/or personal reporting.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette M Andrade, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fresenius Medical Care
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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High-Protein Food Snack for Dialysis Patients
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