Phase 3 Study; Effects of Green Tea Extract on Obese Women With High Level of Low Density Lipoprotein (LDL): a Randomized, Double-blinded, and Cross-over Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- percentage of reduction of LDL-C
研究概览
简要总结
Green tea is one of the most popular beverages in the world. It is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese with high LDL level.
详细描述
Randomized, double-blind, crossover placebo-controlled clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years
- •body mass index (BMI) >= 27 kg/m2
- •fasting low-density-lipoprotein cholesterol (LDL) >= 130mg/dl and (4) willing to participate in this trial.
排除标准
- •serum alanine transaminase > 80 U/L
- •serum creatinine > 1.8 mg/dl
- •breast feeding or pregnancy
- •heart failure, acute myocardial infarction, stroke, heavy injury
- •any other conditions not suitable for trial as evaluated by the physician. -
研究组 & 干预措施
Placebo first
cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks
干预措施: Placebo (Dietary Supplement)
green tea extract first
green tea extract (EGCG) 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally cellulose 500mg tid for 6 weeks total 14 weeks
干预措施: Placebo (Dietary Supplement)
Placebo first
cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks
干预措施: green tea extract (Dietary Supplement)
green tea extract first
green tea extract (EGCG) 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally cellulose 500mg tid for 6 weeks total 14 weeks
干预措施: green tea extract (Dietary Supplement)
结局指标
主要结局
percentage of reduction of LDL-C
时间窗: 6 weeks of treatment
level of LDL-C before intervention minus level of LDL-C after intervention equal to reduction of LDL-C, percentage of reduction of LDL-C equal to the level of reduction of LDL-C divided by level of LDL-C before intervention
次要结局
- HDL-C(6 weeks)
研究者
Chung-Hua Hsu
Dr
National Yang Ming Chiao Tung University