NCT02213549已完成不适用
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Determine the Effect of Ume Paste and Ginger Powder in Prediabetic Subjects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
研究概览
简要总结
This study is designed to evaluate the effect of ume paste and ginger powder on glucose metabolism in prediabetic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Fasting plasma glucose 105-125 mg/dL
排除标准
- •Taking anti-diabetic drugs
- •Taking drugs or functional food that may affect blood glucose level
- •Pregnant or nursing a child
- •Participation in any clinical trial within 90 days of the commencement of the trial
- •Renal or hepatic dysfunction
- •Heart disease
- •History of severe disease and/or major surgery
结局指标
主要结局
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
时间窗: Weeks 0 and 12
Change in fasting plasma glucose from baseline
时间窗: Every 6 weeks (Overall 12 weeks)
次要结局
- Change in HbA1c from baseline(Weeks 0 and 12)
- Change in glycoalbumin from baseline(Weeks 0 and 12)
- Change in fasting insulin from baseline(Weeks 0 and 12)
- Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline(Weeks 0 and 12)
- Change in serum total cholesterol from baseline(Every 6 weeks (Overall 12 weeks))
- Change in serum LDL cholesterol from baseline(Every 6 weeks (Overall 12 weeks))
- Change in serum HDL cholesterol from baseline(Every 6 weeks (Overall 12 weeks))
- Change in serum triglyceride from baseline(Every 6 weeks (Overall 12 weeks))
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (2)
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