High-Protein Food Snack for Dialysis Patients

University of Florida

Status: Completed

Conditions: Renal Failure; Diet Habit; Albumin; Double

Treatments: Other: Protein Food Snack

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04134377

IRB201900310

AGR DTD 06-26-2019 (Other Grant/Funding Number)

OCR21882 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Protein Food Snack

Experimental group

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.

Treatment:

Other: Protein Food Snack