跳至主要内容
临床试验/NCT01789866
NCT01789866已完成不适用

Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function in Healthy Children

University of British Columbia1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
fMRI data

研究概览

简要总结

Studies suggest that lutein and n-3 fatty acids may influence the development of a child's brain and may be related to how well children learn. Both lutein and the n-3 fats (also known as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators are interested to understand the importance of n-3 fats and lutein to child brain development. Functional magnetic resonance imaging (fMRI) will make it possible to look into the brain from the outside and see which parts of the brain are being used as children complete working memory tasks. The investigators will study brain function using fMRI among children with different intakes of n-3 fats and lutein.

Hypothesis:

  1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.
  2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.

详细描述

Study Design:

A cross-sectional observational study of 62 school-age children in Vancouver, Canada.

Dietary intake assessment:

Children's dietary intake over the previous four weeks was estimated by interview with a parent using a Food Frequency Questionnaire. Three 24h recalls were administered, using the five-pass review technique. The children's dietary intake of DHA was quantified using nutrient analysis software (ESHA Food Processor SQL, version 10.10.0.0; ESHA Research), using Canadian foods, and checking the fatty acid composition of all foods and beverages for accuracy, modifying if necessary based on labels or laboratory analysis of the product.

Blood Markers EDTA venous blood was collected and was centrifuged to collect Red Blood Cells (RBC). RBC fatty acids were extracted and quantified by routine gas liquid chromatography. RBC-DHA to DPA (n-6) ratio was used as an indicator of DHA status.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
69 Months 至 78 Months(Child)
性别
All
接受健康志愿者

入选标准

  • full-term
  • single birth (no multiple births)
  • no major illness or surgery requiring hospitalization likely to impact the outcomes
  • no metabolic, congenital or allergic disease that impact food intakes
  • parents have sufficient command of English language to complete the informed consent and study documents
  • The specific inclusion enrollment criteria for:
  • Group 1: children consuming <25 mg/day DHA and < 400 μg/day lutein, n=24; Group 2: children consuming >150 mg/day DHA and >1,200 μg/day lutein, n=24; Group 3: children consuming >150 mg/day DHA and <400 μg/day lutein, n=10;

排除标准

  • children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy
  • children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete
  • children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein
  • children of mothers who do not sign the informed consent
  • any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C&W MRI Patient Screening Form will be excluded from this study.

结局指标

主要结局

fMRI data

时间窗: 5 years 8 months to 6 years

fMRI data will be collected for subjects differentiated by DHA and lutein status completing tasks for working memory, working language, visual working memory and visual acuity

次要结局

  • cognitive development with standardized developmental tests(5 years 8 months to 6 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yvonne Lamers

Principle Investigator

University of British Columbia

研究点 (1)

Loading locations...

相似试验

DHA & Lutein and fMRI Brain Mapping in Healthy... | 临床试验