Acute Effect of Plantago Asiatica L. Extract on Antioxidative Biomarkers in Subjects With Mild Hyperlipidemia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Comet assay after single-dose consumption of Plantago asiatica L. extract
研究概览
简要总结
The purpose of this study is to evaluate the antioxidant effect of Plantago asiatica L. extract in subjects with mild hyperlipidemia.
详细描述
The purpose of this study is to evaluate an acute effect of Plantago asiatica L. extract consumption on antioxidative biomarkers in subjects with mild hyperlipidemia. Subjects will intake Plantago asiatica L. extract with a high fat meal for oxidative stress loading. Antioxidative biomarkers will be measured after single-dose administration of Plantago asiatica L. extract.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults age over 30
- •BMI(Body mass index) between 25 and 33 kg/m2
- •Total cholesterol between 200mg/dL and 250mg/dL OR Triglyceride between 150mg/dL and 220mg/dL OR LDL-cholesterol between 130mg/dL and 165mg/dL
排除标准
- •Subject who has taken part in other clinical trials within 30 days of screening visit
- •Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect antioxidative biomarkers within 30days of screening visit
- •Subject who is pregnant or breast feeding
- •Subject who lost body weight over 4kg within 30days of screening visit
- •Alcoholic
- •Subject who takes excessive exercise (over 7hours/week)
- •Subject who has hypertension(≥140/90mmHg), diabetes(fasting blood glucose ≥126mg/dL), kidney disease, hepatic disease or hyperthyroidism within 2years
- •Subject who has an allergy to the ingredients of study product
研究组 & 干预措施
• Plantago asiatica L. extract 5g
干预措施: Plantago asiatica L. extract 5g (Dietary Supplement)
Plantago asiatica L. extract 10g
干预措施: Plantago asiatica L. extract 10g (Dietary Supplement)
Plantago asiatica L. extract 20g
干预措施: Plantago asiatica L. extract 20g (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Comet assay after single-dose consumption of Plantago asiatica L. extract
时间窗: measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes)
次要结局
- Plasma ox-LDL(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
- Plasma erythrocyte SOD(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
- Plasma triglyceride(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
- Plasma FRAP(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
- Plasma FFA(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
- Plasma MDA(measured 5 times over 6 hours(0, 60, 120, 240, 360 minutes))
研究者
Oran Kwon
Ph.D, Professor
Ewha Womans University