Whey Protein Supplement for Kidney Failure
Trial Summary
What is the purpose of this trial?
This is a 6-month prospective interventional clinical trial designed to evaluate the impact of whey protein isolate oral supplement on protein status. Differences in protein status will be evaluated with review of the medical chart from standard of care monthly blood collection for serum albumin, total protein, and normalized protein catabolic rate (nPCR) as detected by serum urea nitrogen. Mid-arm circumference and weight will be measured to ensure no significant changes. Quality of life will be measured to detect if the addition of protein aided in overall quality of life. There will be a 3-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. After the recruitment period has finished, eligible participants will sign the consent form in order to participate in the study. At this point, participants will be provided the supplements for the month and instructed with the amount of water and how to mix with the provided measuring and drinking cup.
Research Team
Jeanette M Andrade, PhD
Principal Investigator
University of Florida
Eligibility Criteria
Adults over 18 with stage 5 chronic kidney disease (CKD) who have been on peritoneal dialysis for at least three months. Participants must be able to sign consent, have no dietary restrictions, food allergies, or issues with chewing/swallowing. Pregnant or lactating individuals and those using other protein supplements are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 20g total protein of whey protein isolate in 115 mls of water daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Whey protein supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor