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Completed

NCT Number: NCT06154161

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

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.

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Key information

Conditions

Renal Failure Deficiency Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency Protein-Energy Malnutrition Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Dialysis Center, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein Supplement

Dietary 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.

Primary outcomes

  1. Serum albumin

    Time frame: up to 6 months of the study

    Collection of serum albumin to identify a change from pre-post to analyze the effect protein isolate had on inflammation marker and protein status.

Secondary outcomes

  1. Total protein

    Time frame: up to 6 months of the study

    Collection of whole blood total protein to identify a change from pre-post to analyze the effect protein isolates had on protein stores.

  2. normalized protein catabolic rate (nPCR)

    Time frame: up to 6 months of the study

    Collection of nPCR through serum to identify a change from pre-post to analyze the effect protein isolates had on nPCR.

  3. mid-arm muscle circumference

    Time frame: up to 6 months of the study

    measuring mid-arm circumference from baseline to the end of the study to determine that protein isolates did not affect muscle mass.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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