The COOKER-BLADDER Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Diet, Healthy, Urinary Bladder Diseases, Oncogenesis

Intervention / Treatment
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* Other: Dietary regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no daily medication no ongoing medical treatment Exclusion Criteria: Chronic disease Regular medication Not willing to follow diet instructions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focus on bladder protective diet<br>For 12 weeks, healthy volunteers will follow a bladder protective diet. | Other: Dietary regimens<br>* 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.<br>|
| Experimental: No focus on bladder protective diet<br>For 12 weeks, healthy volunteers will not follow a specific diet. | Other: Dietary regimens<br>* 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.<br>|

What is the study measuring?
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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 |