NCT01685944已完成不适用
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Pediococcus Pentosaceus LP28 on Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- BMI
研究概览
简要总结
This study is designed to evaluate efficacy of Pediococcus pentosaceus LP28 in reducing body fat and body weight in subjects with BMI 25-30 kg/m2.
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 medicines 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
结局指标
主要结局
BMI
时间窗: Every day (Overall 14 weeks)
Body weight will be measured every morning.
Body fat
时间窗: Every 4 weeks (Overall 12 weeks)
次要结局
- Fasting blood glucose(Every 4 weeks (Overall 12 weeks))
- Leptin(Weeks 0 and 12)
- Fasting insulin(Weeks 0 and 12)
- Adiponectin(Weeks 0 and 12)
- Resistin(Weeks 0 and 12)
- Abdominal circumference(Every 4 weeks (Overall 12 weeks))
- Serum triglyceride(Every 4 weeks (Overall 12 weeks))
- Total cholesterol(Every 4 weeks (Overall 12 weeks))
- HDL cholesterol(Every 4 weeks (Overall 12 weeks))
- HOMA-R(Weeks 0 and 12)
- LDL cholesterol(Every 4 weeks (Overall 12 weeks))
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (2)
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