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NCT06154161 | COMPLETED | Renal Failure


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

University of Florida

Brief 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.

Condition or disease

Renal Failure

Protein-Energy Malnutrition

Intervention/treatment

Whey protein supplement

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 9 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2024-09-01
Estimated Study Completion Date : 2024-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT06154161


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Locations


Not yet recruiting

United States, Florida

University of Florida

Gainesville, Florida, United States, 32606

Not yet recruiting

United States, Florida

UF Health Dialysis Center

Gainesville, Florida, United States, 32611

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