NCT04134377

High-Protein Food Snack for Dialysis Patients

High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Failure
• Albumin; Double
• Diet Habit

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2019-10-22
• Last updated: 2020-08-24

Locations

1 site across 1 country: United States