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Active, Not Recruiting

NCT Number: NCT04626362

American Cranberries to Prevent UTIs in Susceptible Women

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Food Science and human nutrition department at University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cranberry juice

Other

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

Primary outcomes

  1. baseline urinary anti-adhesion index

    Time frame: day 9 and 10

    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.

Secondary outcomes

  1. Urinary anti-adhesion index after four days of cranberry juice intake

    Time frame: after drinking cranberry juice for 4 days

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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