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

Not Applicable

Completed

• Conditions: Renal Failure; Protein-Energy Malnutrition
• Interventions: Dietary Supplement: Whey protein supplement

• Registration Number: NCT06154161
• Lead Sponsor: University of Florida

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-04
• Study Start: 2024-03-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Whey protein consumption	Whey protein supplement	Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months

Primary Outcome Measures

Name	Time	Method
Serum albumin	up to 6 months of the study	Collection of serum albumin to identify a change from pre-post to analyze the effect protein isolate had on inflammation marker and protein status.

Secondary Outcome Measures

Name	Time	Method
Total protein	up to 6 months of the study	Collection of whole blood total protein to identify a change from pre-post to analyze the effect protein isolates had on protein stores.
normalized protein catabolic rate (nPCR)	up to 6 months of the study	Collection of nPCR through serum to identify a change from pre-post to analyze the effect protein isolates had on nPCR.
mid-arm muscle circumference	up to 6 months of the study	measuring mid-arm circumference from baseline to the end of the study to determine that protein isolates did not affect muscle mass.

Trial Locations

Locations (2)

UF Health Dialysis Center; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States