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临床试验/NCT02375373
NCT02375373已完成不适用

Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation

University of Florida1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.

研究概览

简要总结

This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function.

详细描述

Long-term observational study:

Subjects enrolled will participate in an observational setting for three months. During this time period, individuals will be encouraged, to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples for microbiota analysis will be collected every month. Participants will record a weekly online questionnaire about legume intake and GI health as well as other health status updates. While participants will be encouraged to maintain regular intake of chickpeas throughout the long-term study, consumption of other legumes will be encouraged.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good Health
  • No systemic antibiotics during the preceding two months
  • No medication suppressing immune function
  • Willingness to provide basic demographic as well as medical history data

排除标准

  • Gastric Ulcers
  • Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
  • Chronic constipation/diarrhea
  • Body Mass Index (BMI) > 30
  • Dietary restrictions that prevent legume intake
  • Currently on any medication that can affect GI transit time
  • Consumption of >3 servings/week of chickpeas or >6 servings/week of legumes BEFORE study begins

结局指标

主要结局

Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.

时间窗: Change from Day 31, Day 62, and Day 93

Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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