Status:

COMPLETED

Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis

Lead Sponsor:

University of Florida

Conditions:

Renal Failure

Protein-Energy Malnutrition

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 w...

Eligibility Criteria

Inclusion

  • 18 years old or older
  • diagnosed with stage 5 Chronic Kidney Disease for at least 3 months prior to the starting date of the trial
  • on peritoneal dialysis at least three months prior to the starting date of the trial
  • can provide signed informed consent
  • have no dietary restriction
  • no food allergies
  • no chewing/swallowing difficulties.

Exclusion

  • not meeting the above
  • pregnant/lactating as either self-reported or determined by the medical director
  • Chronic Kidney Disease patient stages 1-4.
  • Chronic Kidney Disease patient undergoing hemodialysis.
  • use of other protein supplement

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2024

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT06154161

Start Date

March 1 2024

End Date

September 1 2024

Last Update

April 4 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Florida

Gainesville, Florida, United States, 32606

2

UF Health Dialysis Center

Gainesville, Florida, United States, 32611