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临床试验/NCT03974126
NCT03974126已完成不适用

Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene

Lund University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Postprandial insulin

研究概览

简要总结

Individuals with low copy numbers of salivary amylase gene have lower salivary amylase levels and might therefore have decreased capacity to metabolize starch into glucose. We will in a randomized crossover meal study examine the postprandial response of high-starch meals in individuals with either low or high copy number of the salivary amylase gene.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Genotype were blinded for the participants and all research staff except for the principal investigator. Amount of bread was not blinded.

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participant in the Malmö Offspring Study
  • •Genotyped for AMY1 copy number variation and selected for having either low (2-4) or high (10 or above) copy number of AMY1
  • •Gender: both males and females
  • •Completed information on dietary habits

排除标准

  • •Allergic to wheat, gluten intolerant or on a low-carbohydrate diet
  • •Inability to eat up to 4 slices of white bread in 15 minutes
  • •Use of medication known to influence glucose metabolism, appetite or saliva flow
  • •Diagnosed diabetes or high fasting plasma glucose (above 6.1 mmol/L)

研究组 & 干预措施

40 grams of starch to low and high AMY1 copy number carriers

Experimental

The postprandial response between individuals that are either carriers of low AMY1 copy numbers (2-4) or high copy numbers (10 or more copies) will be compared

干预措施: 40 grams of starch (Other)

80 grams of starch to low and high AMY1 copy number carriers

Experimental

The postprandial response between individuals that are either carriers of low AMY1 copy numbers (2-4) or high copy numbers (10 or more copies) will be compared

干预措施: 80 grams of starch (Other)

结局指标

主要结局

Postprandial insulin

时间窗: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)

postprandial insulin concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)

Postprandial glucose

时间窗: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)

Postprandial glucose concentration assessed as incremental area under curve over 120 minutes (0, 7, 15, 30, 45, 60 ,90, 120 minutes)

Preabsorptive insulin release

时间窗: 7 minutes

Insulin concentration at 7 minutes

次要结局

  • subjective satiety(0, 15, 30, 45, 60, 90, 120 minutes)
  • salivary amylase activity(0 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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