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

NCT06154161 | Completed

• 1 other identifier: WheyproteinPD
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Failure; Protein-Energy Malnutrition

Keywords

peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Serum albumin

  Collection of serum albumin to identify a change from pre-post to analyze the effect protein isolate had on inflammation marker and protein status.

  up to 6 months of the study

Secondary Outcomes (3)

• Total protein

  up to 6 months of the study

• normalized protein catabolic rate (nPCR)

  up to 6 months of the study

• mid-arm muscle circumference

  up to 6 months of the study

Study Arms (1)

Whey protein consumption

EXPERIMENTAL

Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months

Dietary Supplement: Whey protein supplement

Interventions

Whey protein supplement DIETARY_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.

Whey protein consumption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32606, United States

Location

UF Health Dialysis Center

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jeanette M Andrade, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6-month prospective interventional clinical trial

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 4, 2023
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)