The COOKER-BLADDER Trial

NCT05643963 | Completed

• 1 other identifier: SZB-URO-23-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Diet, Healthy; Urinary Bladder Diseases; Oncogenesis

Outcome Measures

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.

  12 weeks

Secondary Outcomes (6)

• Change in multiplex cytokine levels in voided urine

  12 weeks

• DNA sequences in urinary microbiome

  12 weeks

• Change of BMI

  12 weeks

• Change of heart rate

  12 weeks

• Change of blood pressure

  12 weeks

Study Arms (2)

Focus on bladder protective diet

EXPERIMENTAL

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

Other: Dietary regimens

No focus on bladder protective diet

EXPERIMENTAL

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

Other: Dietary regimens

Interventions

Dietary regimens OTHER

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.

Focus on bladder protective diet; No focus on bladder protective diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no daily medication
• no ongoing medical treatment

You may not qualify if:

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

Sponsors & Collaborators

• Roland Seiler-Blarer: lead

Study Sites (2)

Department of Urology, Spitalzentrum Biel

Biel/Bienne, Canton of Bern, 2501, Switzerland

Location

Roland Seiler

Biel, 2501, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder Diseases; Carcinogenesis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 9, 2022
• Study Start: March 25, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: At publication

Locations

CH (2)