NCT01811511已完成2 期
Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Body Fat Mass
研究概览
简要总结
The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18-29 years old
- •BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women)
- •Able to give informed consent
排除标准
- •Allergic or hypersensitive to any of the ingredients in the test products
- •The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL
- •Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
结局指标
主要结局
Change in Body Fat Mass
时间窗: 12 weeks
Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week).
Changes in Percent Body Fat
时间窗: 12 weeks
Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week).
次要结局
- Change in Glucose(12 weeks)
- Changes in Cholesterol(12 weeks)
研究者
Tae Sun Park
Obesity Research Center of Chonbuk National University
Chonbuk National University Hospital
研究点 (2)
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