High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Serum albumin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Serum albumin
Time Frame: 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 Outcomes
- Serum phosphorus(Up to 12 months)
- Diet Intake(Up to 12 months)