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American Cranberries to Prevent UTIs in Susceptible Women

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ClinicalTrials.gov Identifier: NCT04626362
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The investigators pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine. The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E. coli.

Condition or disease Intervention/treatment Phase
Healthy Other: Cranberry juice Other: Placebo juice Not Applicable

Detailed Description:
The American cranberries (Vaccinium macrocarpon) have been consumed for centuries to prevent urinary tract infections (UTI), which affect 50% of women in their lifetime. However, NIH-funded clinical trials of cranberries on UTI in the last 20 years yielded conflicting results but the reasons are unknown. About 90% of UTI are initiated by adhesion of uropathogenic E. coli on urinary tract epithelia. It was reported that human urine after cranberry intake inhibited the adhesion of E. coli. A-type procyanidins and xyloglucans are the presumed bioactives in cranberries; however, none of these compounds are absorbable in small intestine. They are degraded by microbes in colon.The pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity, suggesting there are polymorphisms in human's ability to metabolize cranberry bioactives. Based on these observations, the investigators formulate a novel hypothesis that not all, but a fraction of women harbor specific gut microbes with the ability to catabolize cranberry bioactives to anti-adhesion metabolites in the urine; therefore, the variation of gut microbiome is the underlying mechanism for metabolic polymorphisms and disparity in UTI prevention. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increase anti-adhesion activity of their urine. The overall objectives are to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of E. coli. The expected result will be to generate strong preliminary data showing the differences of gut microbiome between responders and non-responders in additional to correlations between gut microbes and candidate anti-adhesion biomarkers in the urine of UTI susceptible women.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Experimental: Cranberry juice consumption participants will be provided cranberry juice to consume for 21 days Intervention: Other: Cranberry juice Placebo Comparator: Placebo juice consumption participants will be provided placebo juice to consume for 21 days Intervention: Other: Placebo juice
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach
Actual Study Start Date : February 2, 2021
Estimated Primary Completion Date : November 20, 2023
Estimated Study Completion Date : November 20, 2023

Arm Intervention/treatment
Experimental: Experimental: Cranberry juice consumption
Participants will be provided cranberry juice to consume for 21 days
Other: Cranberry juice
Cranberry juice cocktail will be provided by Ocean Spray Cranberries, Inc.

Experimental: Placebo juice consumption
Participants will be provided placebo juice to consume for 21 days
Other: Placebo juice
Apple juice added with flavor and colorants will be provided by Ocean Spray Cranberries, Inc.




Primary Outcome Measures :
  1. Change in the anti-adhesion activity [ Time Frame: Baseline and 21 days of each intervention ]
    Compare the statistical difference between the changes from baseline in the an-adhesion activity uropathogenic E. coli in UTI-susceptible women after consuming the cranberry beverage for 3 weeks versus the change after consuming the control beverage for 3 weeks. Anti-adhesion activity in urine will be measured using a fluoresces-based micro-plate 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.


Secondary Outcome Measures :
  1. Change in urinary biomarkers [ Time Frame: Baseline and 21 days of each intervention ]
    Compare the statistical difference between the change from baseline in the an-adhesion activity uropathogenic E. coli in UTI-susceptible women after consuming the cranberry beverage for 3 weeks versus the change after consuming the control beverage for 3 weeks. The Urinary biomarkers will be identified and measured using LC-Orbitrap-MS.

  2. Change in gut microbiomes [ Time Frame: Baseline and 21 days of each intervention ]
    Compare the difference between the changes in gut microbiomes between responders and non-responders participants after consuming the cranberry beverage for 3 weeks versus the change after consuming the control beverage for 3 weeks. The gut microbiomes will be measured Genomic microbial DNA the extraction of genomic microbial DNA from fecal samples using DNA isolation kits and the 16S ribosomal RNA gene (V1-3 region) will be amplified and sequenced.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study will determine American cranberries to prevent urinary tract infections (UTIs) in susceptible women.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626362


Contacts
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Contact: Liwei Gu, PhD (352)2943730 lgu@ufl.edu
Contact: Yavuz Yagiz, PhD (352)2943988 yavuzy@ufl.edu

Locations
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United States, Florida
Food Science and human nutrition department at University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Yavuz Yagiz, PhD         
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Liwei Gu, PhD University of Florida
Study Director: Yavuz Yagiz, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04626362    
Other Study ID Numbers: IRB202002624
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Cranberry
UTI