Renal Failure Clinical Trial
Official title:
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Verified date | June 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UF Health Dialysis Center | Gainesville | Florida |
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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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