The COOKER-BLADDER Trial

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05643963
• Other study ID #: SZB-URO-23-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: Roland Seiler, Prof.
• Phone: +41 32 324 32 06
• Email: urology[@]szb-chb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• no daily medication

• no ongoing medical treatment

Exclusion Criteria:

• Chronic disease

• Regular medication

• Not willing to follow diet instructions

Related Conditions & MeSH terms

• Diet, Healthy
• Urinary Bladder Diseases

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Roland Seiler	Biel

Sponsors (1)

Lead Sponsor	Collaborator
Roland Seiler-Blarer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change of BMI	After the 12 week diet period (protective and non-protective) BMI will be assessed.	12 weeks
Secondary	Change of heart rate	After the 12 week diet period (protective and non-protective), heart rate will be assessed.	12 weeks
Secondary	Change of blood pressure	After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.	12 weeks
Secondary	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