Status:
COMPLETED
High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
Lead Sponsor:
University of Florida
Conditions:
Renal Failure
Chronic Kidney Disease Requiring Chronic Dialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cro...
Eligibility Criteria
Inclusion
- 18 years old or older
- diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
- 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
- All participants have the ability to provide signed informed consent
- have not been newly diagnosed
- not present with symptomatic infection of COVID-19
- have no dietary restriction
- no food allergies
- no chewing/swallowing difficulties
Exclusion
- CKD patient stages 1-4.
- CKD patient undergoing peritoneal hemodialysis.
- In isolation due to COVID-19 or other infectious disease
- Adult pregnant and/or lactating for the duration of the study.
- Any other renal disease autoimmune or otherwise.
- Use of other IP within 3 months prior of the eligibility screening.
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05227755
Start Date
August 5 2022
End Date
November 21 2023
Last Update
June 10 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32606