American Cranberries to Prevent UTIs in Susceptible Women
- Conditions
- Healthy
- Registration Number
- NCT04626362
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 55
- Healthy women participants
- BMI 18.5-29.9 kg/m2
- At least 110 pounds in weight
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method baseline urinary anti-adhesion index 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 Outcome Measures
Name Time Method Urinary anti-adhesion index after four days of cranberry juice intake 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.
Trial Locations
- Locations (1)
Food Science and human nutrition department at University of Florida
🇺🇸Gainesville, Florida, United States
Food Science and human nutrition department at University of Florida🇺🇸Gainesville, Florida, United States