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Completed

NCT Number: NCT05643963

The COOKER-BLADDER Trial

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.

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Key information

Conditions

Diet, Healthy Carcinogenesis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplastic Processes Oncogenesis Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Spitalzentrum Biel, Biel/Bienne, Canton of Bern, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no daily medication
  • no ongoing medical treatment

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Change in molecular profile of urothelial cells

    Time frame: 12 weeks

    After the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.

Secondary outcomes

  1. Change in multiplex cytokine levels in voided urine

    Time frame: 12 weeks

    After the 12 week diet period (protective and non-protective), supernatant in voided urine will be used for further examination

  2. DNA sequences in urinary microbiome

    Time frame: 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.

  3. Change of BMI

    Time frame: 12 weeks

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

  4. Change of heart rate

    Time frame: 12 weeks

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

  5. Change of blood pressure

    Time frame: 12 weeks

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

  6. Change of health status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roland Seiler-Blarer

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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