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

University of Florida

Status: Completed

Conditions: Renal Failure; Protein-Energy Malnutrition

Treatments: Dietary Supplement: Whey protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06154161

WheyproteinPD

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Whey protein consumption

Experimental group

Description:

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

Treatment:

Dietary Supplement: Whey protein supplement