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临床试验/NCT04848233
NCT04848233已完成不适用

Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial

DoubleGood AB2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
DoubleGood AB
入组人数
6
试验地点
2
主要终点
Postprandial glucose response

研究概览

简要总结

The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25-29.9 kg/m^2
  • HOMA-IR < 2.5
  • Fasting glucose < 6.1 mmol/L
  • Stable weight since 3 months
  • Access to iPhone with Bluetooth 4.0 and iOS 13 or later

排除标准

  • Pharmacological treatment known to interfer with metabolism
  • Antibiotics treatment the latest 3 months
  • Vegetarian/Vegan diet
  • Use of tobacco
  • Pregnancy or breast-feeding

结局指标

主要结局

Postprandial glucose response

时间窗: From start of meal (0 min) to 120 min postprandially

Incremental area under the blood glucose curve after each meal

次要结局

  • Glycemic variability(24 hour cycles)

研究者

发起方
DoubleGood AB
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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