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The COOKER-BLADDER Trial

modifiCatiOn of fOod intaKe to Influence the Equilibrium of the uRinary BLADDER

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05643963
Enrollment
13
Registered
2022-12-09
Start date
2025-03-25
Completion date
2025-12-02
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Oncogenesis, Urinary Bladder Diseases

Brief 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.

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.

Sponsors

Roland Seiler-Blarer
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* no daily medication * no ongoing medical treatment

Exclusion criteria

* Chronic disease * Regular medication * Not willing to follow diet instructions

Design outcomes

Primary

MeasureTime frameDescription
Change in molecular profile of urothelial cells12 weeksAfter the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.

Secondary

MeasureTime frameDescription
DNA sequences in urinary microbiome12 weeksAfter 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.
Change of BMI12 weeksAfter the 12 week diet period (protective and non-protective) BMI will be assessed.
Change in multiplex cytokine levels in voided urine12 weeksAfter the 12 week diet period (protective and non-protective), supernatant in voided urine will be used for further examination
Change of blood pressure12 weeksAfter the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.
Change of health status12 weeksAfter 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.
Change of heart rate12 weeksAfter the 12 week diet period (protective and non-protective), heart rate will be assessed.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026