Whey Protein Supplement for Kidney Failure

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJeanette M Andrade, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with stage 5 chronic kidney disease (CKD) who have been on peritoneal dialysis for at least three months. Participants must be able to sign consent, have no dietary restrictions, food allergies, or issues with chewing/swallowing. Pregnant or lactating individuals and those using other protein supplements are excluded.

Inclusion Criteria

I have been diagnosed with stage 5 kidney disease for at least 3 months.

I am 18 years old or older.

Can provide signed informed consent

+4 more

Exclusion Criteria

Use of other protein supplement

Pregnant/lactating as either self-reported or determined by the medical director

My kidney disease is between stages 1 to 4.

+1 more

Participant Groups

The trial is testing if a whey protein isolate supplement can improve the protein status in adults undergoing peritoneal dialysis. Over six months, participants' blood will be checked monthly for certain proteins and their body measurements taken to see any changes in nutrition and quality of life.

1Treatment groups

Experimental Treatment

Group I: Whey protein consumptionExperimental Treatment1 Intervention

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