American Cranberries to Prevent UTIs in Susceptible Women

University of Florida

Status: Active, not recruiting

Conditions: Healthy

Treatments: Other: Cranberry juice

Study type: Interventional

Funder types: Other

Identifiers

NCT04626362

IRB202002624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Experimental: Cranberry juice consumption

Experimental group

Description:

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

Treatment:

Other: Cranberry juice