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临床试验/NCT03330366
NCT03330366已完成不适用

An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects

Chonbuk National University Hospital0 个研究点目标入组 30 人开始时间: 2015年11月24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
30
主要终点
Changes of blood glucose during OGTT

研究概览

简要总结

The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.

详细描述

Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Fasting glucose 100~126 mg/dl

排除标准

  • Significant variation in weight (more 10%) in the past 3 months
  • Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months
  • Type 1 diabetes or HbA1c>9.0%
  • Cardiovascular disease
  • Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts
  • Pregnancy or breast feeding

研究组 & 干预措施

Allium hookeri extract

Experimental

take two capsules per day (486 mg/day) for 8 weeks

干预措施: Allium hookeri extract (Dietary Supplement)

Placebo

Placebo Comparator

take two capsules per day for 8 weeks

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Changes of blood glucose during OGTT

时间窗: 8 weeks

Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention

次要结局

  • Changes of HbA1c(8 week)
  • Changes of C-peptide(8 week)
  • Changes of blood insulin(8 week)

研究者

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

Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Chonbuk National University Hospital

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