NCT02050555已完成不适用
A Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in BMI from baseline
研究概览
简要总结
This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight 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
- •BMI 25-30 kg/m2
排除标准
- •Taking drugs or functional food that may affect body weight or body fat
- •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 BMI from baseline
时间窗: Every 4 weeks (Overall 12 weeks)
Change in body fat mass (percentage) from baseline
时间窗: Every 4 weeks (Overall 12 weeks)
次要结局
- Change in serum total cholesterol from baseline(Every 4 weeks (Overall 12 weeks))
- Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline(Weeks 0 and 12)
- Change in abdominal circumference from baseline(Every 4 weeks (Overall 12 weeks))
- Change in visceral fat area by CT scan from baseline(Weeks 0 and 12)
- Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline(Weeks 0 and 12)
- Change in fasting plasma glucose from baseline(Every 4 weeks (Overall 12 weeks))
- Change in serum triglyceride from baseline(Every 4 weeks (Overall 12 weeks))
- Change in fasting insulin from baseline(Weeks 0 and 12)
- Change in serum LDL cholesterol from baseline(Every 4 weeks (Overall 12 weeks))
- Change in serum HDL cholesterol from baseline(Every 4 weeks (Overall 12 weeks))
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (2)
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