To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- baseline urinary anti-adhesion index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women participants
- •BMI 18.5-29.9 kg/m2
- •At least 110 pounds in weight
排除标准
- •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
研究组 & 干预措施
Experimental: Cranberry juice consumption
Participants will be provided with cranberry juice to consume for 4 days after 10 10-day run-in period.
干预措施: Cranberry juice (Other)
结局指标
主要结局
baseline urinary anti-adhesion index
时间窗: 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.
次要结局
- Urinary anti-adhesion index after four days of cranberry juice intake(after drinking cranberry juice for 4 days)
