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临床试验/NCT03078283
NCT03078283已完成不适用

Effects of High-fiber Snack Foods on Human Gut Microbes

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年4月10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
24
试验地点
2
主要终点
Assessment of gut microbial community structure and function

研究概览

简要总结

This is a small-scale study of the effects on microbes in the human gut of adding high-fiber snack foods to usual diet. The snack foods are being provided by Mondelez International, Inc. Eight pairs of dizygotic twins, discordant or concordant for obesity, will participate in the study. They will complete 3 successive experiments in which their regular diet is supplemented by consumption, over a 6-week period, of high-fiber snack foods. Each experiment will involve (i) two weeks consuming regular diet (fecal sample collected weekly); (ii) one week consuming one snack food per day (approximately 7 g fiber, collection of all fecal samples), (iii) one week consuming two snack foods per day (approximately 14 g fiber, collection of all fecal samples), (iv) four weeks consuming three snack foods per day (approximately 20 g fiber, collection of all fecal samples); and (v) two weeks consuming only regular diet (weekly collection of fecal sample). For each experiment, participants will also provide a fasting blood sample during the free diet phase at the end of the week just before initiation of snack consumption, and a fasting blood sample at the end of the last week of snack consumption. Participants will also collect one first morning urine sample weekly throughout the study. During week 2, participants will also collect first morning urine samples for 3 consecutive days. Similarly, they will collect first morning urine samples for the last 3 consecutive days of the last week of snack consumption. The study will test the effects of the different fiber-rich snacks on the composition and metabolic properties of the gut microbial community in lean and obese subjects.

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
31 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • * member of female dizygotic twin pair discordant or concordant for obesity

排除标准

  • pregnant or trying to get pregnant
  • inflammatory bowel disease
  • gastrointestinal cancer
  • hepatitis
  • renal failure
  • food allergies

结局指标

主要结局

Assessment of gut microbial community structure and function

时间窗: 8 weeks

Sequencing bacterial 16S rRNA amplicons plus shotgun sequencing of fecal community DNA to identify effects of fiber-enriched foods on bacterial community and gene representation; mass spectrometry of products of gut microbial community metabolism.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey I. Gordon

Dr. Robert J. Glaser Distinguished University Professor

Washington University School of Medicine

研究点 (2)

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