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The COOKER-BLADDER Trial

Primary Purpose

Diet, Healthy, Urinary Bladder Diseases, Oncogenesis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Dietary regimens
Sponsored by
Roland Seiler-Blarer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet, Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Roland Seiler

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Focus on bladder protective diet

No focus on bladder protective diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2022
Last Updated
December 1, 2022
Sponsor
Roland Seiler-Blarer
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1. Study Identification

Unique Protocol Identification Number
NCT05643963
Brief Title
The COOKER-BLADDER Trial
Official Title
modifiCatiOn of fOod intaKe to Influence the Equilibrium of the uRinary BLADDER
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Roland Seiler-Blarer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, Urinary Bladder Diseases, Oncogenesis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Focus on bladder protective diet
Arm Type
Experimental
Arm Description
For 12 weeks, healthy volunteers will follow a bladder protective diet.
Arm Title
No focus on bladder protective diet
Arm Type
Experimental
Arm Description
For 12 weeks, healthy volunteers will not follow a specific diet.
Intervention Type
Other
Intervention Name(s)
Dietary regimens
Intervention Description
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 Outcome Measure Information:
Title
Change in molecular profile of urothelial cells
Description
After the 12 week diet period (protective and non-protective), cells voided in urine will be sampled and examined.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in multiplex cytokine levels in voided urine
Description
After the 12 week diet period (protective and non-protective), supernatant in voided urine will be used for further examination
Time Frame
12 weeks
Title
DNA sequences in urinary microbiome
Description
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.
Time Frame
12 weeks
Title
Change of BMI
Description
After the 12 week diet period (protective and non-protective) BMI will be assessed.
Time Frame
12 weeks
Title
Change of heart rate
Description
After the 12 week diet period (protective and non-protective), heart rate will be assessed.
Time Frame
12 weeks
Title
Change of blood pressure
Description
After the 12 week diet period (protective and non-protective), systolic and diastolic blood pressure will be assessed.
Time Frame
12 weeks
Title
Change of health status
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: no daily medication no ongoing medical treatment Exclusion Criteria: Chronic disease Regular medication Not willing to follow diet instructions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland Seiler, Prof.
Phone
+41 32 324 32 06
Email
urology@szb-chb.ch
Facility Information:
Facility Name
Roland Seiler
City
Biel
ZIP/Postal Code
2501
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from biomarker assessment and diet regimens will be provided in the general public
IPD Sharing Time Frame
At publication

Learn more about this trial

The COOKER-BLADDER Trial

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