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Completed

NCT Number: NCT04134377

High-Protein Food Snack for Dialysis Patients

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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Key information

Conditions

Renal Failure Albumin; Double Behavior Behavior, Animal Diet Habit Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fresenius Medical Care

Gainesville, Florida, 32606, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Serum phosphorus

    Time frame: 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.

  2. Diet Intake

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Fresenius Medical Care North America
  • National Kidney Foundation, United States

Registry information

Official study title

High-Protein Food Snack and Albumin Outcomes in Hemodialysis Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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