NCT02300181已完成不适用
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Determine the Effect of the Flour Fermentation Products by Bacillus Subtilis Var Natto DC-15 on Postprandial Glucose Profile in Prediabetic Subjects.
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
- 20
- 试验地点
- 1
- 主要终点
- Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
研究概览
简要总结
The purpose of the present study is to evaluate the effect of the extract of the flour fermented with Bacillus subtilis var natto DC-15 on postprandial glucose level in subjects 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 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 110-125 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
研究组 & 干预措施
Placebo (flour)
Placebo Comparator
5 placebo capsules for each test (4.88 kcal/5 cap)
干预措施: Placebo (Dietary Supplement)
Bacillus subtilis var natto DC-15
Experimental
5 experimental capsules for each test (4.96 kcal/5 cap) Extract powder of the flour fermented with Bacillus subtilis var natto DC-15
干预措施: Bacillus subtilis var natto DC-15 (Dietary Supplement)
结局指标
主要结局
Difference in plasma glucose profile including AUC and Cmax after taking 50 g carbohidrate.
时间窗: Overall 3 hours
次要结局
未报告次要终点
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (1)
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