High-Protein Food Snack for Dialysis Patients

NCT04134377 | Completed

• 3 other identifiers: IRB201900310AGR DTD 06-26-2019OCR21882
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure; Albumin; Double; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Serum phosphorus

  Up to 12 months

• Diet Intake

  Up to 12 months

Study Arms (1)

Protein Food Snack

EXPERIMENTAL

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

Interventions

Protein Food Snack OTHER

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.

Protein Food Snack

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Fresenius Medical Care North America: collaborator
• National Kidney Foundation, United States: collaborator

Study Sites (1)

Fresenius Medical Care

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Feeding Behavior

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior, Animal; Behavior

Study Officials

• Jeanette M Andrade, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 22, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)