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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06154161
• Other study ID #: WheyproteinPD
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Protein-Energy Malnutrition
• Renal Failure

Intervention

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.

Locations

Country	Name	City	State
United States	UF Health Dialysis Center	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

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