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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04626362
Enrollment
55
Registered
2020-11-12
Start date
2021-02-02
Completion date
2026-08-20
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cranberry, UTI

Brief summary

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.

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.

Interventions

Cranberry juice cocktail is a product of Ocean Spray Cranberries, Inc.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
baseline urinary anti-adhesion indexday 9 and 10During 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.

Secondary

MeasureTime frameDescription
Urinary anti-adhesion index after four days of cranberry juice intakeafter drinking cranberry juice for 4 daysAfter 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026