High-Protein Food Snack for Dialysis Patients

Not Applicable

Completed

• Conditions: Renal Failure; Diet Habit; Albumin; Double
• Interventions: Other: Protein Food Snack

• Registration Number: NCT04134377
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-19
• Study First Posted: 2019-10-22
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Protein Food Snack	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.

Primary Outcome Measures

Name	Time	Method
Serum albumin	Up to 12 months	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

Name	Time	Method
Serum phosphorus	Up to 12 months	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	Up to 12 months	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.

Trial Locations

Locations (1)

Fresenius Medical Care; 🇺🇸 Gainesville, Florida, United States