Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory and Language in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant
研究概览
简要总结
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E.
详细描述
This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E. This supplement will be taken orally, once a day for 9-10 months starting immediately after delivery. The investigators will also collect a dry blood spot (DBS) from the heel of the infant at 4 and 9 months of age to assess the amount of these nutrients reaching the infants' blood. At these same ages, the investigators will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for mothers at time of recruitment:
- •Intention to breast feed for at least the first 3 months
- •18 years of age or older
- •Willingness to abstain from multi-vitamins or other supplements that contain lutein and vitamin E during the study and take no more than 200 mg of DHA.
- •Normal or corrected-to-normal vision
- •Normal or corrected-to-normal hearing
- •English is the dominant language spoken in the home.
排除标准
- •and/or early termination:
- •Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport.
- •High risk pregnant mothers
- •Macular Pigment Optical Density (MPOD) score greater than 0.
- •Preterm birth (less than 37 weeks)
- •Low birth weight (less than 2500 grams, < 5.5 pounds)
- •Unable or unwilling to continue breast feeding within the first 3 months after birth.
- •Unable or unwilling to continue taking the study supplement within the first 3 months after birth.
结局指标
主要结局
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant
时间窗: Brain activity will be assessed at 4 months of age
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 4 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant
时间窗: Brain activity will be assessed at 9 months of age
The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 9 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
次要结局
- Infant Dry Blood Spot at 4 months(4 months of age)
- Infant Dry Blood Spot at 9 months(9 months of age)