NCT04850352已完成不适用
A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea(Heukcha) Extracts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in fasting triglycerides
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.
详细描述
This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects older than 19 years old
- •Who has fasting blood triglyceride levels ≥ 150 mg/dL
- •Who voluntarily agreed to participate in the study and signed an informed consent form
排除标准
- •Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation
- •Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation
- •Fasting plasma glucose >126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin
- •Who has used or is expected to inevitably use prohibited concomitant medications during the study
- •Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
- •Who has dosed other study medications within 30 days before screening
- •Who is determined ineligible for study participation by investigators for any other reasons
结局指标
主要结局
Change in fasting triglycerides
时间窗: Baseline, Week 4 and Week 8
次要结局
- Change in total cholesterol, LDL-C, HDL-C(Baseline, Week 4 and Week 8)
- Change in BMI (kg/m2)(Baseline, Week 4 and Week 8)
- Change in Waist circumference (cm)(Baseline, Week 4 and Week 8)
研究者
研究点 (4)
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