Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 3
- 主要终点
- Hippocampal-dependent Relational memory
研究概览
简要总结
The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement.
详细描述
This clinical trial will be a randomized placebo-controlled double-blind trial to examine the effects of carotenoid supplementation on cognitive control, hippocampal-dependent relational memory, and academic achievement among pre-adolescents over one school year (i.e. 9-months).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child assent and parent/guardian consent
- •8-10 years of age
- •No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day)
- •Absence of learning disability (parent-reported)
- •Tanner scale score ≤ 2
- •20/20 or corrected vision
排除标准
- •Non-assent of child or non-consent of guardian
- •Above/below 8-10 years of age
- •Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day)
- •Identified learning disability (parent-reported)
- •Tanner scale score > 2
- •Not 20/20 or uncorrected vision
研究组 & 干预措施
Placebo Control
The placebo control group participants will be asked to consume a placebo supplement for 9 months.
干预措施: Placebo control (Dietary Supplement)
Active Supplement
The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months.
干预措施: Active supplement (Dietary Supplement)
结局指标
主要结局
Hippocampal-dependent Relational memory
时间窗: 9 months (Baseline vs Follow-up)
Spatial memory task accuracy
Attentional Accuracy
时间窗: 9 months (Baseline vs Follow-up)
Changes in accuracy (%) between groups using a computerized flanker task.
Composite Academic Achievement
时间窗: 9 months (Baseline vs Follow-up)
Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Attentional Reaction Time
时间窗: 9 months (Baseline vs Follow-up)
Changes in reaction time (ms) between groups using a computerized flanker task.
次要结局
- Macular Pigment Optical Density(9 months (Baseline vs Follow-up))
- Attentional Resource Allocation(9 months (Baseline vs Follow-up))
- Written Language(9 months (Baseline vs Follow-up))
- Reading Fluency(9 months (Baseline vs Follow-up))
- Attentional Processing Speed(9 months (Baseline vs Follow-up))
- Math(9 months (Baseline vs Follow-up))
- Reading(9 months (Baseline vs Follow-up))