Effects of Lycopene Supplementation on Oxidative Stress and Markers of Endothelial Function in Healthy Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- lymphocyte DNA damage
研究概览
简要总结
The hypothesis was that an increase in serum lycopene levels following supplementation with capsules containing natural lycopene rich tomato extract would reduce oxidative stress and improve endothelial function in healthy men with low intake of fruits and vegetables. A randomized double-blind, placebo-controlled study was designed to assess the changes in serum lycopene levels, oxidative stress and endothelial function in response to an 8-week treatment with lycopene supplementation.
详细描述
The healthy men aged 20-60 years, who frequently smoked cigarettes or consumed alcohol, were enrolled in this study. Subjects were excluded if they consumed more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods; took antioxidant, vitamin, or mineral supplements; had any history of chronic disease; or were taking lipid-lowering or antihypertensive medications.The subjects were randomly assigned to receive placebo, 6mg, or 15mg lycopene capsule per day for 8 weeks. Study substances were suspended in soybean oil and given in acid-soluble gelatin capsules. A placebo containing soybean oil (100%) was supplied in identical-looking capsules. All the subjects were instructed to consume one capsule per day right after any meal of their choice. All participants were encouraged to maintain their usual lifestyle and dietary habits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy men who frequently smoked cigarettes or consumed alcohol
排除标准
- •consumption of more than 3 servings/day of vegetables and fruit, or more than one serving/week of lycopene-rich foods
- •taking antioxidant, vitamin, or mineral supplements
- •any history of chronic disease (diabetes, heart disease, renal disease)
- •taking lipid-lowering or antihypertensive medications
结局指标
主要结局
lymphocyte DNA damage
时间窗: 8 weeks
antioxidant enzymes : SOD, GSH-Px, Catalase
时间窗: 8 weeks
lipid peroxidation marker : MDA, urinary 8 epi-PGF 2alpha
时间窗: 8 weeks
oxidized LDL
时间窗: 8 weeks
次要结局
- Reactive hyperemia peripheral arterial tonometry (RH-PAT) index(8 weeks)
- VCAM-1/ICAM-1(8 weeks)
- cytokines : IL-6, TNF-alpha, IL-1beta(8 weeks)
- hs-CRP(8 weeks)