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Clinical Trials/NCT05643963
NCT05643963
Completed
Not Applicable

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

Roland Seiler-Blarer2 sites in 1 country13 target enrollmentMarch 25, 2025
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ConditionsDiet, HealthyUrinary Bladder DiseasesOncogenesis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
Roland Seiler-Blarer
Enrollment
13
Locations
2
Primary Endpoint
Change in molecular profile of urothelial cells
Status
Completed
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2025
End Date
December 2, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Roland Seiler-Blarer
Responsible Party
Sponsor Investigator
Principal Investigator

Roland Seiler-Blarer

Prof. Dr. med.

Hospital Centre Biel/Bienne

Eligibility Criteria

Inclusion Criteria

  • •no daily medication
  • •no ongoing medical treatment

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Change in multiplex cytokine levels in voided urine(12 weeks)
  • DNA sequences in urinary microbiome(12 weeks)
  • Change of BMI(12 weeks)
  • Change of heart rate(12 weeks)
  • Change of blood pressure(12 weeks)
  • Change of health status(12 weeks)

Study Sites (2)

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