Effects of Lutein Supplementation on Cognition and Vision in Healthy Children With Screen Time Exposure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Macular Pigment Optical Density - heterochromatic flicker photometry
研究概览
简要总结
This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.
详细描述
Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Each participant will be assigned to a group based on a permuted block randomization stratified by participant self-reported sex. Participants may identify male, female or other. If other is selected, assignment as male or female for randomization purposes will be determined by a coin flip. Randomized block lists with a size of 4 will be prepared using a computer generated random number sequence, http://www.jerrydallal.com/random/assigndoc.htm#num (J. Kim & Shin, 2014). Based on group placement, participants will be provided with Bottle A or Bottle B of gummies to last for the next 90 days.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 8 to 16 years
- •guardian-reported general good health
- •guardian-reported 4 hours or more of digital screen time daily
排除标准
- •Currently using a supplement containing lutein or zeaxanthin
结局指标
主要结局
Macular Pigment Optical Density - heterochromatic flicker photometry
时间窗: 6 months
Level of macular carotenoids deposited in the eye measured using the psychophysical technique of heterochromatic flicker photometry (QuantifEye MPS-II Device). Minimum score of 0, no maximum. Average values range from 0.0 to 1.0. Higher numbers represent greater macular pigment.
Macular Pigment Optical Density - haidinger's brushes
时间窗: 6 months
Level of macular carotenoids deposited in the eye measured using haidinger's brushes (Azul Optics MP-Eye Device). Minimum score of 0, maximum score of 10. Higher values represent greater macular pigment.
次要结局
- Digital Eye strain change from baseline(6 months)
- Sleep score change from baseline(6 months)
- Verbal Fluency(6 months)
研究者
Brenda Fonseca
Principal Investigator
Northcentral University