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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06154161
Other study ID # WheyproteinPD
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 1, 2025

Study information

Verified date June 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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