American Cranberries to Prevent UTIs in Susceptible Women

NCT ID: NCT04626362

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2026-08-20

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Experimental: Cranberry juice consumption

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

Group Type: EXPERIMENTAL

Cranberry juice

Intervention Type: OTHER

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

Interventions

Cranberry juice

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liwei Gu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Yavuz Yagiz, PhD

Role: STUDY_DIRECTOR

University of Florida

Locations

Food Science and human nutrition department at University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202002624

Identifier Type: -

Identifier Source: org_study_id