NCT06154161

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Renal Failure
• Protein-Energy Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whey protein supplement	A monthly supply of 35 g of whey protein isolate will be provided to participants in individual sachet packets with instructions of preparation. Every month, participants will come to the center to provide the standard monthly blood sample. At this time, the PI will have participants complete the quality-of-life instrument, ask if there have been any changes in their dietary habits, and collect weights for up to 6-months. Additionally, participants will indicate if they had consumed the protein daily and/or bring back their empty/full satchel packets. As this is a feasibility trial, it is necessary to determine the compliancy of consuming protein daily and the amount. Furthermore, understanding how protein markers may be affected by consumption of the protein daily vs less frequently throughout the week is important to establish improved recommendations for consumption of protein supplements.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-12-04
• Last updated: 2025-04-04

Locations

2 sites across 1 country: United States