NCT02019368已完成不适用
A Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Antioxidant Effect of Aged Garlic Extract in Heavy Smokers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary 8-hydroxydeoxyguanosine (8-OHdG)
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, crossover study to determine the antioxidant effect of aged garlic extract. This study will also compare the oxidative status in heavy smokers with that in non-smokers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Smoking (at least 20 cigarettes per day) or non-smoking (more than 20 years)
排除标准
- •Under medication for chronic disease
- •Garlic allergy
- •Engaging in vigorous exercise
- •Taking drugs or functional food that may possess antioxidant property
- •Participation in any clinical trial within 90 days of the commencement of the trial
- •Renal or hepatic dysfunction
- •Heart disease
研究组 & 干预措施
Placebo
Placebo Comparator
Smoker subjects take 6 capsules once a day for 4 weeks.
干预措施: Placebo (Dietary Supplement)
Non-smoker
No Intervention
Oxidative status in non-smoker
Aged garlic extract
Experimental
Smoker subjects take 1.5 g of aged garlic extract in 6 capsules once a day for 4 weeks.
干预措施: Aged garlic extract (Dietary Supplement)
结局指标
主要结局
Urinary 8-hydroxydeoxyguanosine (8-OHdG)
时间窗: Every 4 weeks (Overall 12 weeks)
次要结局
- High sensitive CRP(Every 4 weeks (Overall 12 weeks))
- Blood pressure(Every 4 weeks (Overall 12 weeks))
- Indices of the second derivative of photoplethysmogram (SDPTG)(Every 4 weeks (Overall 12 weeks))
研究者
Fumiko Higashikawa
Associate Professor
Hiroshima University
研究点 (1)
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