A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Blueberry Dry Powder on Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in fasting plasma glucose from baseline
研究概览
简要总结
The purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (OGTT), or HbA1c) in subjects with prediabetes.
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 110-125 mg/dL
排除标准
- •Taking anti-diabetic drugs
- •Taking drugs or functional food that may affect blood glucose level
- •Fruit allergy
- •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
研究组 & 干预措施
Low dose of blueberry dry powder
0.5 g blueberry dry powder, twice a day for 12 weeks
干预措施: Low dose of blueberry dry powder (Dietary Supplement)
High dose of blueberry dry powder
5.0 g blueberry dry powder, twice a day for 12 weeks
干预措施: High dose of blueberry dry powder (Dietary Supplement)
结局指标
主要结局
Change in fasting plasma glucose from baseline
时间窗: Every 6 weeks (Overall 12 weeks)
Change in HbA1c from baseline
时间窗: Weeks 0 and 12
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline
时间窗: Weeks 0 and 12
次要结局
- Change in serum C-peptide from baseline(Weeks 0 and 12)
- Change in glycoalbumin from baseline(Every 6 weeks (Overall 12 weeks))
- 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)
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University