Diet, HealthyNCT05643963
The COOKER-BLADDER Trial
A study testing Dietary regimens in people with Diet, Healthy and Urinary Bladder Diseases, run by Roland Seiler-Blarer at 2 sites in Switzerland.
Trial summary
The goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. The main questions it aims to answer are: How does food intake modify the characteristics of urothelial cells? Does change of specific diet regimes influence biomarker characteristics in urine?… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Urinary Bladder Diseases, Oncogenesis
- What is being tested?
- Dietary regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 25 Mar 2025to 2 Dec 2025
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no daily medication
- no ongoing medical treatment
Who cannot join
- Chronic disease
- Regular medication
- Not willing to follow diet instructions
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Roland Seiler
Biel, 2501
Department of Urology, Spitalzentrum Biel
Biel/Bienne, Canton of Bern, 2501
About this study
Official title: modifiCatiOn of fOod intaKe to Influence the Equilibrium of the uRinary BLADDER
The goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. The main questions it aims to answer are:
- How does food intake modify the characteristics of urothelial cells?
- Does change of specific diet regimes influence biomarker characteristics in urine? Participants will follow specific diet regime for a given time period. After completion of this period biomarker assessment is performed. Thereafter the participants follow an opposite diet regime for the same time period with identical biomarker assessment at the end.
Biomarkers within the participants and between the diet regimes will be compared to investigate the influence of food intake on the urinary bladder.
- Conditions
- Diet, Healthy, Urinary Bladder Diseases, Oncogenesis
- Being tested
- Dietary regimens
- Medical subject headings
- Urinary Bladder Diseases, Carcinogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary regimensOther
Food intake will follow a recommendation according to a specific list. Protective and non-protective food intake will be performed for specific time periods with biomarker assessment after each period.
| Study group | Role | What they receive |
|---|---|---|
| Focus on bladder protective diet | Experimental | For 12 weeks, healthy volunteers will follow a bladder protective diet. Receives: Other: Dietary regimens |
| No focus on bladder protective diet | Experimental | For 12 weeks, healthy volunteers will not follow a specific diet. Receives: Other: Dietary regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in molecular profile of urothelial cells
After the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.
Measured: 12 weeks
Secondary outcomes (6)
Change in multiplex cytokine levels in voided urine
After the 12 week diet period (protective and non-protective), supernatant in voided urine will be used for further examination
Measured: 12 weeks
DNA sequences in urinary microbiome
After the 12 week diet period (protective and non-protective), DNA sequencing on urinary microbiome in voided urine will be performed and compared between the different dietary regimens.
Measured: 12 weeks
Change of BMI
After the 12 week diet period (protective and non-protective) BMI will be assessed.
Measured: 12 weeks
Change of heart rate
After the 12 week diet period (protective and non-protective), heart rate will be assessed.
Measured: 12 weeks
Change of blood pressure
After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.
Measured: 12 weeks
Change of health status
After the 12 week diet period (protective and non-protective), health status will be assessed using the Short Form 36 (SF-36) questionaire.
The possible score ranges from 0 to 100 points, with 0 points representing the greatest possible health limitation, and 100 points representing no health limitation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start25 Mar 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roland Seiler-Blarer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roland Seiler-Blarer, Hospital Centre Biel/Bienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643963
- Sponsor's protocol ID
- SZB-URO-23-001
- Status last verified
- Dec 2025
- First submitted
- 4 Nov 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from biomarker assessment and diet regimens will be provided in the general public
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- modifiCatiOn of fOod intaKe to Influence the Equilibrium of the uRinary BLADDER
- ClinicalTrials.gov ID
- NCT05643963
- Acronym / sponsor ID
- SZB-URO-23-001
- Conditions
- Diet, Healthy, Urinary Bladder Diseases, Oncogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Roland Seiler-BlarerUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 9 Dec 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 goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. The main questions it aims to answer are:
- How does food intake modify the characteristics of urothelial cells?
- Does change of specific diet regimes influence biomarker characteristics in urine? Participants will follow specific diet regime for a given time period. After completion of this period biomarker assessment is performed. Thereafter the participants follow an opposite diet regime for the same time period with identical biomarker assessment at the end.
Biomarkers within the participants and between the diet regimes will be compared to investigate the influence of food intake on the urinary bladder.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus on bladder protective diet | Experimental | Other: Dietary regimensFor 12 weeks, healthy volunteers will follow a bladder protective diet. |
| No focus on bladder protective diet | Experimental | Other: Dietary regimensFor 12 weeks, healthy volunteers will not follow a specific diet. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no daily medication
- no ongoing medical treatment
Key exclusion criteria (3 listed)
- Chronic disease
- Regular medication
- Not willing to follow diet instructions
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 |
|---|---|---|
| Dietary regimensFood intake will follow a recommendation according to a specific list. Protective and non-protective food intake will be performed for specific time periods with biomarker assessment after each period. | Other | Focus on bladder protective diet, No focus on bladder protective diet |
Primary outcome
Change in molecular profile of urothelial cells
Time frame: 12 weeks
After the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.
6 secondary outcomes
Change in multiplex cytokine levels in voided urine
Time frame: 12 weeks
DNA sequences in urinary microbiome
Time frame: 12 weeks
Change of BMI
Time frame: 12 weeks
Change of heart rate
Time frame: 12 weeks
Change of blood pressure
Time frame: 12 weeks
Change of health status
Time frame: 12 weeks
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 11 Dec 2025.
- Individual participant dataSharing planned: Yes. Data from biomarker assessment and diet regimens will be provided in the general public
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary regimens in people with Diet, Healthy and Urinary Bladder Diseases, run by Roland Seiler-Blarer at 2 sites in Switzerland.
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 3 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 11 Dec 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 Switzerland. 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?
Change in molecular profile of urothelial cells (time frame: 12 weeks). 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 11 Dec 2025.