NCT00449917已完成4 期
Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- macular pigment optical density
研究概览
简要总结
The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.
详细描述
Visiobiane study is a randomized trial of 30 participants designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15 subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age). They will be supplemented for 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy caucasian men
- •age : 45-55
- •BMI < 25
排除标准
- •non healthy
- •retinian and/or visual anomaly
- •Ocular media not clear enough to allow good fundus photography
结局指标
主要结局
macular pigment optical density
次要结局
- contrast sensibility
- visual acuity
- seric carotenoids concentrations
- total antioxidant capacity
- influence of SR-B1 genetic polimorphism
研究者
研究点 (2)
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