American Cranberries to Prevent UTIs in Susceptible Women

NCT04626362 | Active Not Recruiting

• 1 other identifier: IRB202002624
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Cranberry; UTI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  after drinking cranberry juice for 4 days

Study Arms (1)

Experimental: Cranberry juice consumption

EXPERIMENTAL

Participants will be provided with cranberry juice to consume for 4 days after 10 10-day run-in period.

Other: Cranberry juice

Interventions

Cranberry juice OTHER

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

Experimental: Cranberry juice consumption

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: UTI predominantly affect women and is rare in men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women participants
• BMI 18.5-29.9 kg/m2
• At least 110 pounds in weight

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Food Science and human nutrition department at University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Liwei Gu, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Yavuz Yagiz, PhD

  University of Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 12, 2020
• Study Start: February 2, 2021
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)