American Cranberries to Prevent UTIs in Susceptible Women

To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach

The investigator's 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 increases anti-adhesion activity of their urine.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Cranberry juice

Detailed Description

The American cranberries (Vaccinium macrocarpon) have been consumed for centuries to prevent urinary tract infections (UTIs), 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 UTIs 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 the small intestine. They are degraded by microbes in the colon. The pre-preliminary study showed that the urine from a portion of study participants had anti-adhesion activity, suggesting there are polymorphisms in humans' ability to metabolize cranberry bioactives. The investigators propose that UTI susceptible women can be divided into responders and non-responders depending on whether cranberry intake increases anti-adhesion activity of their urine.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Food Science and human nutrition department at University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Cranberry juice consumption; Participants will be provided with cranberry juice to consume for 4 days after 10 10-day run-in period.	Other: Cranberry juice; Cranberry juice cocktail is a product of Ocean Spray Cranberries, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
baseline urinary anti-adhesion index	During the 10-day run-in period, all the participants will be given a list of foods to avoid, including cranberries, blueberries, grapes, apples, plums, chocolate, and green tea. Two self-collected baseline urine samples will be provided by participants on the mornings of days 9 and 10. Anti-adhesion activity of urine against E coli will be assessed using a fluorescent method.	day 9 and 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary anti-adhesion index after four days of cranberry juice intake	After urine collection in the last two days of the run-in period, participants will maintain their dietary restriction for an additional 2-7 days and allow the anti-adhesion activity of baseline urine to be tested. Afterward, part of the participants will be selected to consume cranberry juice for four days. Each participant drank two bottles of cranberry cocktail containing 27% juice per day. A post-consumption urine sample will be self-collected by each participant on the morning of day 5. Anti-adhesion activity of urine against E coli will be assessed using a fluorescent method.	after drinking cranberry juice for 4 days

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Study Director: Yavuz Yagiz, PhD, University of Florida; Principal Investigator: Liwei Gu, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: UTI; Cranberry
• Other Study ID Numbers: IRB202002624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No