Albumin; Double, Diet Habit, Renal Failure
Conditions
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.
Interventions
OTHERProtein 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.
Sponsors
Fresenius Medical Care North America
National Kidney Foundation, United States
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed