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临床试验/NCT05112133
NCT05112133已完成不适用

Effect of Mulberry Leaf Extract on Glucose Response of a Test Meal

Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月24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
入组人数
24
试验地点
2
主要终点
Post-prandial glucose

研究概览

简要总结

The aim of this study is to test the effects of Mulberry leaf extract on glucose response of a standardized complete meal when taken just before or when mixed with the meal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female participants
  • Healthy status (based on anamnesis)
  • Age between 18 and 45 years
  • BMI between 20 and 29.9 kg/m2
  • Ability to understand and sign an informed consent form

排除标准

  • Pregnant or lactating women
  • Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
  • Known food allergy and intolerance to test product
  • Medically known cutaneous hypersensitivity to adhesives and plasters
  • Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
  • Volunteer who cannot be expected to comply with the protocol
  • Subject having a hierarchical link with the research team members.

结局指标

主要结局

Post-prandial glucose

时间窗: Hour 0 to hour 3 after standard meal consumption

Incremental area under the curve

次要结局

  • C max glucose(Hour 0 to hour 3 after standard meal consumption)
  • T max glucose(Hour 0 to hour 3 after standard meal consumption)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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