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临床试验/NCT03957239
NCT03957239已完成不适用

The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults With a BMI ≥ 30: a Randomized, Double-blind, Controlled, Crossover Study

University of Florida2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in Gastroduodenal permeability

研究概览

简要总结

In this double blind, crossover study participants will consume a cranberry beverage and a cranberry-flavored beverage for 2 weeks each. Gut permeability will be assessed weekly using aspirin and food-grade sugar molecules. Participants will be asked to provide urine, blood, saliva and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the cranberry beverage

详细描述

Obesity, stress, liver disease, alcoholism, diabetes, and autoimmune diseases in humans or animal models are associated with altered intestinal permeability; consequently, maintenance of the gastrointestinal barrier is an emerging area of interest. The purpose of this randomized, double-blind, controlled crossover study is to compare the difference between the change from baseline in gastroduodenal permeability after drinking a cranberry or control beverage for two weeks. Gastroduodenal permeability will be assessed following aspirin challenge by measuring urinary sucrose in the 0 to 5-hour urine collection after differential sugar probes are consumed. Urine will be collected for an additional 19 hours (24 hours total) to assess whole gut permeability. A 4-week washout period will separate the interventions. Stool and fasting blood and saliva samples will be obtained before and during the intervention periods to assess fecal microbial communities and markers of intestinal barrier, immune function and oxidative stress. It is anticipated that cranberry juice will selectively increase intestinal Akkermansia bacteria, reduce markers of inflammation and oxidative stress, increase mucosal immunity, and protect the gastroduodenal barrier from an aspirin challenge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Gastroduodenal permeability

时间窗: Baseline and Week 2 of each intervention

Compare the statistical difference between the change from baseline (i.e., final - baseline) in gastroduodenal permeability after consuming the cranberry beverage for 2 weeks versus the change after consuming the control beverage for 2 weeks. Gastroduodenal permeability will be assessed following aspirin challenge by measuring urinary sucrose in the 0 to 5-hour urine collection.

次要结局

  • Change in Colonic permeability(Baseline and Week 2 of each intervention)
  • Change in Whole gut permeability(Baseline and Week 2 of each intervention)
  • Change in Stool consistency(Baseline and Week 2 of each intervention)
  • Change in Stool frequency(Baseline and Week 2 of each intervention)
  • Change in Small intestinal permeability(Baseline and Week 2 of each intervention)
  • Change in Bacterial species of interest(Baseline and Week 2 of each intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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