High-Protein Food Snack for Dialysis Patients

Renal Failure Clinical Trial

Official title:

High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134377
• Other study ID #: IRB201900310
• Secondary ID: AGR DTD 06-26-20
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Albumin; Double
• Diet Habit
• Renal Failure
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Fresenius Medical Care	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Fresenius Medical Care North America, National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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