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临床试验/NCT01449383
NCT01449383已完成不适用

Molecular Targets Open for Regulation by the Gut Flora - New Avenues for Improved Diet to Optimize European Health (TORANDO): WP2 Individual Intervention Studies- Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

German Institute of Human Nutrition0 个研究点目标入组 20 人开始时间: 2010年11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
主要终点
change in gut microbiota composition

研究概览

简要总结

This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.

详细描述

Human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. Due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. Examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.

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
None

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

  • age 20 to 60
  • obtained informed consent
  • willing and able to consume defined diets
  • willing and able to collect all intended samples

排除标准

  • prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer
  • Antibiotic treatment within the last three month before start of studies
  • Prevalent gastrointestinal diseases, disorders and surgeries
  • Pregnancy and breastfeeding

结局指标

主要结局

change in gut microbiota composition

时间窗: baseline, week 3, 6 and 9

次要结局

  • change in anthropometry(baseline, week 3, 6 and 9)
  • change in blood markers(baseline, week 3, 6 and 9)
  • change in salivary microbial composition(baseline, week 3, 6 and 9)

研究者

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

Jana Foerster

Jana Foerster, PhD student

German Institute of Human Nutrition

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