High-Protein Food Snack for Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Failure Albumin; Double Diet Habit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Protein Food Snack

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.

Group Type EXPERIMENTAL

Protein Food Snack

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes