Clinical trial NCT04626362: American Cranberries to Prevent UTIs in Susceptible Women
Official title: To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Cranberry
UTI
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: baseline urinary anti-adhesion index
timeFrame: day 9 and 10
Secondary outcomes:
measure: Urinary anti-adhesion index after four days of cranberry juice intake
timeFrame: after drinking cranberry juice for 4 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Food Science and human nutrition department at University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Liwei Gu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Yavuz Yagiz, PhD
role: STUDY_DIRECTOR
References: