Healthy Clinical Trial
Official title:
Investigate the Roles of Gut Microbiome in the Differential Responses of UTI Susceptible Women to Cranberry Juice Intake
Verified date | May 2023 |
Source | University of Florida |
Contact | Liwei Gu, PhD |
Phone | 3522943730 |
lgu[@]ufl.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Clinical trials on cranberry juice and UTI prevention yielded both positive and negative results for unknown reason. Gut microbiome in women affect the absorption and metabolism of cranberry bioactives. The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention in women.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | August 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - Healthy women participants; - BMI 18.5-29.9 kg/m2; - At least 110 pounds in weight Exclusion Criteria: - BMI= 30 kg/m2; - Pregnancy and breast-feeding; - Smoking, frequent alcohol use; - History of any clinically important disorder that may interfere with interpretation of the results; - Intake of medication that might influence the outcome of the study |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | United States Department of Agriculture (USDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the unrinary anti-adhesion activity of UTI susceptible women | Compare the statistical differences between the changes from baseline in the an-adhesion activity against uropathogenic E. coli in UTI-susceptible women after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks. Anti-adhesion activity in urine will be measured using a fluorescence-based microplate method. The anti-adhesion activities of urines will be expressed by its equivalence to myricetin level. The unit for urine anti-adhesion activities is µg myricetin/mg creatinine. | Baseline up to 21 days of each intervention | |
Secondary | Determine the compositional differences of gut microbiome in responders and non-responders after the cranberry juice intake | Compare the differences in the gut microbiomes between responders and non-responders after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks. Human feces collected from responders and non-responders will be analyzed for microbiota composition. Relative abundance of gut microbiome at phylum level, family level, genus level, and Firmicutes over Bacteroidetes ratio will be evaluated. Genomic microbial DNA will be extracted from fecal samples using DNA isolation kits. The 16S ribosomal RNA gene (V1-3 region) of each sample will be amplified and sequenced using a barcoding system on a MiSeq sequencer. Sequence data will be analyzed using the latest version of QIIME. | Baseline up to 21 days of each intervention | |
Secondary | Identify anti-adhesion urinary biomarkers in responders versus non-responders after the cranberry juice intake | Determine the impacts of cranberry juice intake on the urinary metabolome and identify anti-adhesion urinary biomarkers in responders and non-responders after consuming the cranberry juice for 3 weeks versus after consuming the placebo juice for 3 weeks. Metabolites in urine will be detected using UHPLC-HRMS and annotated using combination of m/z and retention time. Metabolites that significantly contribute to the anti-adhesion activity of urine revealed by PLS regression analysis are the potential anti-adhesion biomarkers. A list of potential biomarkers will be generated. Structures of these biomarkers will be tentatively determined through spectral analysis and database searching. Structure of tentatively identified biomarkers will be confirmed by comparing with authentic standards. | Baseline upt to 21 days of each intervention |
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