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临床试验/NCT01518088
NCT01518088已完成不适用

Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control

Ingredion Incorporated2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年2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
20
试验地点
2
主要终点
Metabolizable energy

研究概览

简要总结

The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Body mass index from 25 to 35 kg/m
  • Willing to consume study foods and comply with dietary exclusions and specimen collection

排除标准

  • Pregnancy
  • Gastrointestinal disease
  • Regular use of pre- or probiotics
  • Recent use of antibiotics
  • High intake of dietary fiber

结局指标

主要结局

Metabolizable energy

时间窗: 7 days, 3 times

Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy

Fermentability

时间窗: One, eight-hr day, three times

Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period

次要结局

  • Blood glucose(For eight hours, three times)
  • Fecal microbiota(2 days, three times, and 7 days, three times)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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