Kidney Stone PreventionNCT05460247
Protein Sources Urinary Stone Risk
A study testing Protein in people with Kidney Stone Prevention, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Prior studies have shown that the source of dietary protein can have a significant impact on urinary stone risk. However, whey and plant protein isolates have not been compared. This is an important distinction as protein supplements fortified foods are increasingly popular. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone Prevention
- What is being tested?
- Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2022to 30 Jul 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to complete the study
- Healthy with no personal or family history of kidney stones
Who cannot join
- Allergy to any protein isolates or menu items used in the study
- History of calcium oxalate, cysteine, uric acid, or infection stones
- Disorders of absorption: Celiac disease, Irritable Bowel Disease, chronic diarrhea, short gut
- Systemic predisposition to stones: gout, congenital hyperuricemia, chronic diarrhea, insulin resistance, neoplastic disorders, hyperparathyroidism or renal tubular acidosis
- Women who are currently pregnant or planning pregnancy within 2 years
- Renal transplant recipient
Show all 22Show fewer
- Bedridden study participants (ECOG ≥ 3)
- Uncorrected anatomical obstruction of the urinary tract
- History of recurrent urinary tract infections (> 3 urinary tract infections/year proven by urine culture)
- Exclusions due to medication use:
- Chronic use of lithium
- Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)
- Intake of narcotic medication on a daily basis for >30 days prior to enrollment
- Supplemental Vitamin C (> 1 g daily)
- Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)
- high dose calcium supplementation (> 1,200 mg daily)
- Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
- Non-English Speakers
- History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney
- Psychiatric conditions impairing compliance with the study
- Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact participant's ability to complete study activities)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63110
Daniel Wong, MD
About this study
Official title: The Effect of Protein Sources on Urinary Stone Risk
Prior studies have shown that the source of dietary protein can have a significant impact on urinary stone risk. However, whey and plant protein isolates have not been compared. This is an important distinction as protein supplements fortified foods are increasingly popular. Herein, we seek to investigate the effect of different protein supplements, in an otherwise identical diet, on urinary stone risk.
Read the detailed description
Each participant will receive a pre-made diet for 5 days at a time, for a total of 4 cycles. Previous studies have shown urine values reach a constant within the first 3 days. Diet will be a constant baseline diet representative of a standard Mediterranean diet. Participants will receive this diet to eat at home for 5 days with a supplemental protein shake at each meal (3 times a day). Participants will be required to drink 2.5-3 liters of fluid daily. Caffeine may be ingested as caffeine pills. Excessive exercise will be discouraged during the treatment phase.
Diet will remain constant with respect to protein quantity and all other ingredients and will only change protein isolate source in supplemental protein shake.
On days 4 and 5 of the diet, participants will be asked to collect two consecutive 24-hour urines. Between each 5-day diet phase, a flexible washout period will be allowed in which participants may eat a self-selected diet to take a break from standardized meals. Participants may resume the next phase diet on a day which is convenient for planned 24-hour urine collection at the end of that phase. The break period is to last no longer than 10 days.
- Conditions
- Kidney Stone Prevention
- Being tested
- Protein
- Keywords
- Nephrolithiasis, Kidney stones, Protein
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteinDietary supplement
Participants will receive a diet supplemented by the above protein
| Study group | Role | What they receive |
|---|---|---|
| Pea protein diet | Experimental | Not described Receives: Dietary Supplement: Protein |
| Whey protein diet | Experimental | Not described Receives: Dietary Supplement: Protein |
| Soy protein | Experimental | Not described Receives: Dietary Supplement: Protein |
| Rice protein | Experimental | Not described Receives: Dietary Supplement: Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary stone risk
24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid
Measured: 3 months after beginning study
Calcium Oxalate Inhibitor activity
mmol of Oxalate added before spontaneous precipitation
Measured: 3-6 months after beginning study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Oct 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Stone PreventionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460247
- Sponsor's protocol ID
- Proteinsourcesv1
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2022
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Sources on Urinary Stone Risk
- ClinicalTrials.gov ID
- NCT05460247
- Acronym / sponsor ID
- Proteinsourcesv1
- Conditions
- Kidney Stone Prevention
- Keywords
- Nephrolithiasis, Kidney stones, Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 15 Jul 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.
Prior studies have shown that the source of dietary protein can have a significant impact on urinary stone risk. However, whey and plant protein isolates have not been compared. This is an important distinction as protein supplements fortified foods are increasingly popular. Herein, we seek to investigate the effect of different protein supplements, in an otherwise identical diet, on urinary stone risk.
Detailed description
Each participant will receive a pre-made diet for 5 days at a time, for a total of 4 cycles. Previous studies have shown urine values reach a constant within the first 3 days. Diet will be a constant baseline diet representative of a standard Mediterranean diet. Participants will receive this diet to eat at home for 5 days with a supplemental protein shake at each meal (3 times a day). Participants will be required to drink 2.5-3 liters of fluid daily. Caffeine may be ingested as caffeine pills. Excessive exercise will be discouraged during the treatment phase.
Diet will remain constant with respect to protein quantity and all other ingredients and will only change protein isolate source in supplemental protein shake.
On days 4 and 5 of the diet, participants will be asked to collect two consecutive 24-hour urines. Between each 5-day diet phase, a flexible washout period will be allowed in which participants may eat a self-selected diet to take a break from standardized meals. Participants may resume the next phase diet on a day which is convenient for planned 24-hour urine collection at the end of that phase. The break period is to last no longer than 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pea protein diet | Experimental | Dietary Supplement: Protein |
| Whey protein diet | Experimental | Dietary Supplement: Protein |
| Soy protein | Experimental | Dietary Supplement: Protein |
| Rice protein | Experimental | Dietary Supplement: Protein |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to complete the study
- Healthy with no personal or family history of kidney stones
Key exclusion criteria (22 listed)
- Allergy to any protein isolates or menu items used in the study
- History of calcium oxalate, cysteine, uric acid, or infection stones
- Disorders of absorption: Celiac disease, Irritable Bowel Disease, chronic diarrhea, short gut
- Systemic predisposition to stones: gout, congenital hyperuricemia, chronic diarrhea, insulin resistance, neoplastic disorders, hyperparathyroidism or renal tubular acidosis
- Women who are currently pregnant or planning pregnancy within 2 years
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 |
|---|---|---|
| ProteinParticipants will receive a diet supplemented by the above protein | Dietary supplement | Pea protein diet, Rice protein, Soy protein, Whey protein diet |
Primary outcome
Urinary stone risk
Time frame: 3 months after beginning study
24 hour urine panel and supersaturation for Calcium Oxalate and Uric Acid
Calcium Oxalate Inhibitor activity
Time frame: 3-6 months after beginning study
mmol of Oxalate added before spontaneous precipitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein in people with Kidney Stone Prevention, run by Washington University School of Medicine 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 2 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Black (3143936572, Blackl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary stone risk (time frame: 3 months after beginning study). The study lists 2 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 24 Apr 2023.