The COOKER-BLADDER Trial

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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder Diseases; Diet, Healthy; Oncogenesis
• Intervention / Treatment: Other: Dietary regimens

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• no daily medication
• no ongoing medical treatment

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focus on bladder protective diet; For 12 weeks, healthy volunteers will follow a bladder protective diet.	Other: Dietary 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.
Experimental: No focus on bladder protective diet; For 12 weeks, healthy volunteers will not follow a specific diet.	Other: Dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	12 weeks
Change of BMI	After the 12 week diet period (protective and non-protective) BMI will be assessed.	12 weeks
Change of heart rate	After the 12 week diet period (protective and non-protective), heart rate will be assessed.	12 weeks
Change of blood pressure	After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Roland Seiler-Blarer

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Carcinogenesis
• Other Study ID Numbers: SZB-URO-23-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from biomarker assessment and diet regimens will be provided in the general public
• IPD Sharing Time Frame: At publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No