The COOKER-BLADDER Trial

Not Applicable

Recruiting

• Conditions: Urinary Bladder Diseases; Diet, Healthy; Oncogenesis

• Registration Number: NCT05643963
• Lead Sponsor: Roland Seiler-Blarer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Status Verified: 2025-03
• Study Start: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• no daily medication
• no ongoing medical treatment

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in molecular profile of urothelial cells	12 weeks	After the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.

Secondary Outcome Measures

Name	Time	Method
Change in multiplex cytokine levels in voided urine	12 weeks	After the 12 week diet period (protective and non-protective), supernatant in voided urine will be used for further examination
DNA sequences in urinary microbiome	12 weeks	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.
Change of BMI	12 weeks	After the 12 week diet period (protective and non-protective) BMI will be assessed.
Change of heart rate	12 weeks	After the 12 week diet period (protective and non-protective), heart rate will be assessed.
Change of blood pressure	12 weeks	After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.
Change of health status	12 weeks	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.

Trial Locations

Locations (2)

Department of Urology, Spitalzentrum Biel; 🇨🇭 Biel/Bienne, BE, Switzerland

Roland Seiler; 🇨🇭 Biel, Switzerland