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临床试验/NCT02427555
NCT02427555已完成不适用

Effects of Barley Based Food Products on Metabolism and Gut Microflora

Lund University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年4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
100
试验地点
2
主要终点
Changes in colonic microbiota composition after intervention with barley

研究概览

简要总结

The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.

详细描述

100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.

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
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • healthy men and women between 50-79 years and
  • BMI between 19-28.

排除标准

  • fasting blood glucose concentrations > 6,1 mmol/L,
  • known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
  • furthermore, the subjects should be non-smokers and
  • consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
  • antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.

结局指标

主要结局

Changes in colonic microbiota composition after intervention with barley

时间窗: Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread

Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively

Changes in glucose regulation

时间窗: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread

blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively

nucleotide polymorphisms (SNP in TCF7L2)

时间窗: at baseline

investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2

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

Anne Nilsson

Associate professor, PhD

Lund University

研究点 (2)

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