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临床试验/NCT04626362
NCT04626362已完成不适用

To Determine the Metabolic Polymorphisms of American Cranberries to Prevent UTIs in Susceptible Women Using an Integrated Metabolome-Microbiome Approach

University of Florida1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年2月2日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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