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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focus on bladder protective diet | Experimental | For 12 weeks, healthy volunteers will follow a bladder protective diet. |
|
| No focus on bladder protective diet | Experimental | For 12 weeks, healthy volunteers will not follow a specific diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Spitalzentrum Biel | Biel/Bienne | Canton of Bern | 2501 | Switzerland | ||
| Roland Seiler |
Data from biomarker assessment and diet regimens will be provided in the general public
At publication
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| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D063646 | Carcinogenesis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| Biel |
| 2501 |
| Switzerland |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |