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临床试验/NCT04101344
NCT04101344已完成不适用

Effect of Dietary Supplementation With Fiber Blends on the Gut Microbiota and Host Metabolome and Proteome

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年8月26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
14
试验地点
2
主要终点
Effect of fiber blend snacks on gut microbiota

研究概览

简要总结

The purpose of this research study is to determine whether consuming snacks containing different blends of dietary fibers alters the type and number of bacteria found in your gut and improves markers of overall health.

详细描述

All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome). The information gained from this work will increase our understanding of the importance of specific dietary fibers in manipulating the composition of the gut microbiota in ways that may improve our metabolic health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI ≥25.0 and ≤35.0 kg/m2
  • ≥18 and ≤60 years

排除标准

  • previous bariatric surgery
  • significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney, liver or cardiovascular disease)
  • cancer or cancer that has been in remission for <5 years
  • major psychiatric illness
  • inflammatory gastrointestinal disease
  • pregnant or lactating women
  • use of medications that are known to affect the study outcome measures and that cannot be temporarily discontinued for this study
  • use of medications known to affect the composition of the gut microbiota within the last 30 days (most notably antibiotics)
  • bowel movements <3 times per week
  • vegans, vegetarians, those with lactose intolerance and/or severe allergies/aversions/sensitivities to foods and ingredients included in the prescribed meal plan
  • persons who are not able to grant voluntary informed consent
  • persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.

结局指标

主要结局

Effect of fiber blend snacks on gut microbiota

时间窗: 1 year

Stool samples will be analyzed to determine changes in type and number of gut microbiota.

次要结局

  • Effect of fiber blend snacks in blood and urine(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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