High-Protein Food Snack for Dialysis Patients

High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Diet Habit; Albumin; Double
• Intervention / Treatment: Other: Protein Food Snack

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • Fresenius Medical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Protein Food Snack; 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.

Other: Protein Food Snack; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months
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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Fresenius Medical Care North America; National Kidney Foundation
• Investigators: Principal Investigator: Jeanette M Andrade, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 19, 2019
• First Posted (ACTUAL): October 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: IRB201900310; AGR DTD 06-26-2019 (OTHER_GRANT: National Kidney Foundation); OCR21882 (OTHER: UF ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No