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CompletedNCT05643963Updated Dec 11, 2025

The COOKER-BLADDER Trial

An interventional study of Dietary regimens in Diet, Healthy, Urinary Bladder Diseases and Oncogenesis, sponsored by Roland Seiler-Blarer. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Roland Seiler-Blarer · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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? 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.

02

Conditions studied

  • Diet, Healthy
  • Urinary Bladder Diseases
  • Oncogenesis
03

In context

Urinary Bladder Diseases

62 studies on the registry are indexed under Urinary Bladder Diseases; 9 are open to participants now.

This study's enrollment of 13 is below the median of 79 across 42 interventional studies indexed under Urinary Bladder Diseases.

Browse Urinary Bladder Diseases studies →

Lead sponsor

Roland Seiler-Blarer is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • no daily medication
  • no ongoing medical treatment

Exclusion criteria

Exclusion Criteria:

  • Chronic disease
  • Regular medication
  • Not willing to follow diet instructions
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Focus on bladder protective diet

    For 12 weeks, healthy volunteers will follow a bladder protective diet.

    Other: Dietary regimens

  • Experimental
    No focus on bladder protective diet

    For 12 weeks, healthy volunteers will not follow a specific diet.

    Other: Dietary regimens

Interventions

  • OtherDietary regimens

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. Change of BMI

    After the 12 week diet period (protective and non-protective) BMI will be assessed.

    Time frame: 12 weeks

  4. Change of heart rate

    After the 12 week diet period (protective and non-protective), heart rate will be assessed.

    Time frame: 12 weeks

  5. Change of blood pressure

    After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

07

Study locations

2 sites
  • Department of Urology, Spitalzentrum Biel
    Biel/Bienne, Canton of Bern 2501, Switzerland
  • Roland Seiler
    Biel, 2501, Switzerland
08

References and documents

Individual participant data

Plan to share: Yes — Data from biomarker assessment and diet regimens will be provided in the general public

Supporting information: Study protocol, Analytic code

Time frame: At publication

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2025 to primary completion in Dec 2025, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2022
First posted
Dec 9, 2022
StartActual
Mar 25, 2025
Primary completionActual
Dec 2, 2025
CompletionActual
Dec 2, 2025
Last update
Dec 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05643963
Lead sponsor
Roland Seiler-Blarer
Responsible party
Roland Seiler-Blarer (Prof. Dr. med., Hospital Centre Biel/Bienne) — Sponsor-investigator
First posted
Dec 9, 2022
Start date
Mar 25, 2025
Primary completion
Dec 2, 2025
Completion
Dec 2, 2025
Last update
Dec 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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