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临床试验/NCT05091801
NCT05091801已完成不适用

Effects of Increased Chewing Efficiency on the Gut Microbiome

Duke University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography

研究概览

简要总结

This study is designed to test the effects of chewing efficiency on human gut microbiome composition and function.

详细描述

Our working hypothesis is that increased chewing will lead to an increase in short-chain fatty acid production We further expect this effect to lead to a detectable decrease in fecal particle size and distinct changes in gut microbial community composition. Here, we will explore this hypothesis using a fixed-order within-subjects study design in a group of healthy participants. Each participant will have one week of normal dietary habits and one week of increased chewing time. We will collect stool samples three times per week in order to measure microbial abundance and metabolism.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above age 18?
  • Able to provide stool samples at no risk to yourself?
  • Do you have card access to the CIEMAS building (work in CIEMAS, in Pratt School, or undergraduate at Duke), and are you able to visit this building (at times of your own convenience) for the purposes of this study?

排除标准

  • Oral antibiotic treatment within the past month?
  • Have a history or current diagnosis of irritable bowel syndrome?
  • Have a history or current diagnosis of inflammatory bowel disease?
  • Have a history or current diagnosis of type 2 diabetes?
  • Have a history or current diagnosis of chronic kidney disease with decreased kidney function?
  • Have a history or current diagnosis of intestinal obstruction?
  • Have a history or current diagnosis of untreated colorectal cancer?
  • Have you had a colonoscopy within the past month?
  • Had oral antibiotics within the past month?
  • Do you consume one entire non-snack meal or more per week in liquid form (smoothie, meal replacement drink, etc.)?
  • Do you have any dental issues or other physical limitations that would prevent you from thoroughly chewing your food?
  • Do you currently practice any mindfulness or dietary techniques that involve making sure that your food is chewed thoroughly?

结局指标

主要结局

• Change in short-chain fatty acid (SCFA) measured in stool samples by gas chromatography

时间窗: 1 week baseline and 1 week intervention

次要结局

  • Change in gut microbiome composition as measured by 16S rRNA-encoding gene amplicon sequence analysis(1 week baseline and 1 week intervention)
  • Change in median fecal particle size as measured by laser diffraction(1 week baseline and 1 week intervention)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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