跳至主要内容
临床试验/NCT03944343
NCT03944343已完成不适用

Validation of a New Antidiabetic Food Concept Based on the Modulation of the Intestinal Flora

Lund University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年10月15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
19
试验地点
2
主要终点
Glucose tolerance

研究概览

简要总结

The primary purpose of this project is to evaluate effects in healthy humans on glucose tolerance of cereal products with high amounts of fermentable dietary fibre. Secondary issues are to investigate effects of the test foods on subjective appetite variables, mood variables and gut microbiota composition. The test food products will be consumed in the evening and test variables will be determined the next morning. The study will apply a randomized crossover study design.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18.5 - 25 kg/m2
  • age 20-40 years
  • normal diet

排除标准

  • fasting blood glucose >6.1
  • diagnosed or known disease
  • known gastrointestinal disorder
  • food allergies or intolerance
  • special diet regiments

结局指标

主要结局

Glucose tolerance

时间窗: 3 hours

The incremental (3 hours) blood glucose area under the curve after a standardized breakfast, following consumption of the test- or reference products the previous evening. Glucose concentrations will be analysed from capillary blood at fasting and at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min after the standardized breakfast.

次要结局

  • Mood parameters(3 hours)
  • Breath hydrogen(3 hours)
  • Subjective appetite variables(3 hours)

研究者

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

Anne Nilsson

Associate professor, senior lecturer

Lund University

研究点 (2)

Loading locations...

相似试验