Renal FailureNCT05227755
High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
A study testing Soy protein isolate and Whey protein isolate in people with Renal Failure and Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Florida at 1 site in United States.
Trial summary
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Soy protein isolate and Whey protein isolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 21 Nov 2023
- 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 CKD for at least 3 months prior to the starting date of the trial
- 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
- All participants have the ability to provide signed informed consent
- have not been newly diagnosed
- not present with symptomatic infection of COVID-19
Show all 9Show fewer
- have no dietary restriction
- no food allergies
- no chewing/swallowing difficulties
Who cannot join
- CKD patient stages 1-4.
- CKD patient undergoing peritoneal hemodialysis.
- In isolation due to COVID-19 or other infectious disease
- Adult pregnant and/or lactating for the duration of the study.
- Any other renal disease autoimmune or otherwise.
- Use of other IP within 3 months prior of the eligibility screening.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.
- Being tested
- Soy protein isolate, Whey protein isolate
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy protein isolateDietary supplement
Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.
Whey protein isolateDietary supplement
Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whey protein isolate | Active comparator | Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. Receives: Dietary Supplement: Whey protein isolate |
| Soy protein isolate | Experimental | Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. Receives: Dietary Supplement: Soy protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
Measured: Up to 12 weeks of the study
IL-6
Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
Measured: Up to 12 weeks of the study
Normalized protein catabolic rate
Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.
Measured: Up to 12 weeks of the study
Secondary outcomes (4)
Isoflavones - Serum values of Genistin and Daidzin
Collection of serum isoflavones (genistin and daidzin) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via HPLC.
Measured: Up to 12 weeks of the study
Uremic toxins - serum p-cresol sulfate and indoxyl sulfate
Collection of serum uremic toxins (p-cresol sulfate and indoxyl sulfate) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via LC/MS.
Measured: Up to 12 weeks of the study
Serum Amino acid profiles of essential and non-essential amino acids
Collection of serum amino acid profile of essential and non-essential amino acids to identify a change from pre-post to analyze the effect amino acids had on inflammation markers that will be assessed via LC/MS.
Measured: Up to 12 weeks of the study
Malnutrition Inflammation Score
Assessment of malnutrition at baseline and post-intervention to determine nutritional status. There are a total of 10 questions that participants will answer. Scores are from as low as 0 to as high for 3 for each question. A score of 0 indicates normal whereas a score of 30 indicates severe malnutrition.
Measured: Up to 12 weeks 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 posted7 Feb 2022
- Study start5 Aug 2022
- Primary completion31 Aug 2023
- Study completion21 Nov 2023
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 12-week interventional, double-blind randomized controlled crossover clinical trial designed to evaluate the impact of whey (control) and soy (intervention) protein isolate oral supplements on protein status and inflammation markers.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227755
- Sponsor's protocol ID
- IRB202101921
- Other IDs
- OCR41389
- Status last verified
- Jun 2024
- First submitted
- 21 Dec 2021
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers
- ClinicalTrials.gov ID
- NCT05227755
- Acronym / sponsor ID
- IRB202101921
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 7 Feb 2022 (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.
The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a 12-week interventional, double-blind randomized controlled crossover clinical trial designed to evaluate the impact of whey (control) and soy (intervention) protein isolate oral supplements on protein status and inflammation markers.
| Arm | Type | Receives |
|---|---|---|
| Whey protein isolate | Active comparator | Dietary Supplement: Whey protein isolateParticipants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. |
| Soy protein isolate | Experimental | Dietary Supplement: Soy protein isolateParticipants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old or older
- diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
- 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
- All participants have the ability to provide signed informed consent
- have not been newly diagnosed
Key exclusion criteria (6 listed)
- CKD patient stages 1-4.
- CKD patient undergoing peritoneal hemodialysis.
- In isolation due to COVID-19 or other infectious disease
- Adult pregnant and/or lactating for the duration of the study.
- Any other renal disease autoimmune or otherwise.
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 |
|---|---|---|
| Soy protein isolateParticipants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. | Dietary supplement | Soy protein isolate |
| Whey protein isolateParticipants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks. | Dietary supplement | Whey protein isolate |
Primary outcome
C-reactive protein
Time frame: Up to 12 weeks of the study
Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
IL-6
Time frame: Up to 12 weeks of the study
Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.
Normalized protein catabolic rate
Time frame: Up to 12 weeks of the study
Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.
4 secondary outcomes
Isoflavones - Serum values of Genistin and Daidzin
Time frame: Up to 12 weeks of the study
Uremic toxins - serum p-cresol sulfate and indoxyl sulfate
Time frame: Up to 12 weeks of the study
Serum Amino acid profiles of essential and non-essential amino acids
Time frame: Up to 12 weeks of the study
Malnutrition Inflammation Score
Time frame: Up to 12 weeks 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 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein isolate and Whey protein isolate in people with Renal Failure and Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Florida at 1 site 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 9 inclusion and 6 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
C-reactive protein (time frame: Up to 12 weeks of the study). The study lists 3 primary outcomes in all. 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 10 Jun 2024.