Renal FailureNCT06154161
Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
A study testing Whey protein supplement in people with Renal Failure and Protein-Energy Malnutrition, run by University of Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Protein-Energy Malnutrition
- What is being tested?
- Whey protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida
Gainesville, Florida, 32606
UF Health Dialysis Center
Gainesville, Florida, 32611
About this study
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.
- Conditions
- Renal Failure, Protein-Energy Malnutrition
- Being tested
- Whey protein supplement
- Keywords
- peritoneal dialysis
- Medical subject headings
- Renal Insufficiency, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein consumption | Experimental | Participants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months Receives: Dietary Supplement: Whey protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months of the study
Secondary outcomes (3)
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.
Measured: up to 6 months of the study
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.
Measured: up to 6 months of the study
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.
Measured: up to 6 months of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6-month prospective interventional clinical trial
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanette M Andrade, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154161
- Sponsor's protocol ID
- WheyproteinPD
- Status last verified
- Apr 2025
- First submitted
- 21 Nov 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data and files will be secured in locked filling cabinets and office space. Paper questionnaires will only include date and research study assigned participant number. Data that is originally captured as hardcopy/paper (e.g. questionnaires) will be transcribed to encrypted electronic files. Following the completion of the study, any potential identifiers will be removed from data to meet HIPAA de-identification standards (According to the October 2002 Privacy Rule § 164.514.(b).2. the indicated information/will be removed from all study records). Upon publication, de-identified data can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of High-protein Oral Supplement on Protein Status of Adults on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT06154161
- Acronym / sponsor ID
- WheyproteinPD
- Conditions
- Renal Failure, Protein-Energy Malnutrition
- Keywords
- peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6-month prospective interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Whey protein consumption | Experimental | Dietary Supplement: Whey protein supplementParticipants will receive 20g total protein of whey protein isolate in 115 mls of water to consume daily for up to 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- not meeting the above
- pregnant/lactating as either self-reported or determined by the medical director
- use of other protein supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementA 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. | Dietary supplement | Whey protein consumption |
Primary outcome
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.
3 secondary outcomes
Total protein
Time frame: up to 6 months of the study
normalized protein catabolic rate (nPCR)
Time frame: up to 6 months of the study
mid-arm muscle circumference
Time frame: up to 6 months of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. Data and files will be secured in locked filling cabinets and office space. Paper questionnaires will only include date and research study assigned participant number. Data that is originally captured as hardcopy/paper (e.g. questionnaires) will be transcribed to encrypted electronic files. Following the completion of the study, any potential identifiers will be removed from data to meet HIPAA de-identification standards (According to the October 2002 Privacy Rule § 164.514.(b).2. the indicated information/will be removed from all study records). Upon publication, de-identified data can be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanette M Andrade, PhD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement in people with Renal Failure and Protein-Energy Malnutrition, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum albumin (time frame: up to 6 months of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.