跳至主要内容
临床试验/NCT01634776
NCT01634776已完成不适用

Behavioral, Genetic, and Epigenetic Implications of Dietary Supplementation With Alpha-linolenic Acid in Humans.

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2009年2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
66
试验地点
2
主要终点
Change in declarative memory performance

研究概览

简要总结

Fatty acids or omega-3s are important in the human diet for brain development. Of the three main omega-3s (alpha-linolenic acid: ALA, 18:3n-3; eicosapentaenoic acid: EPA; 20:5n-3; docosahexaenoic acid: DHA, 22:6n-3), DHA and EPA have been studied extensively and have been shown to be important in brain function. Conversely, little is known about the effects of ALA even though the body can make DHA and EPA from it. Because the rate at which ALA makes DHA and EPA is very slow, ALA is not considered an important source of DHA and EPA. However, in the human diet, ALA is more readily available, more easily consumed, and less expensive relative to animal sources of DHA and EPA. So, it is very important that the investigators explore the effects of supplementation with ALA. It is possible that the ALA to DHA and EPA conversion rate can be altered by methylation, an epigenetic form of gene expression and regulation. In the present study, the investigators will examine memory abilities and genetic baselines in 16-month-olds. The investigators will then supplement their food with ALA or control oil for 4 months. At 20 months, the investigators will collect outcome data on memory, fatty acid status, genetic variations, and methylation. The investigators hypothesize that the ALA supplementation will result in an increase in the rate of ALA to DHA and EPA conversion through methylation and genetic variations and subsequently, memory abilities will improve. The data from this study will be used to design a larger R01 grant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Months 至 16 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 16-month-old toddlers and their natural mothers
  • Born fullterm and healthy with no complications
  • English as first language

排除标准

  • Any toddler with a documented neurological or blood disorder will be excluded.

结局指标

主要结局

Change in declarative memory performance

时间窗: Baseline, 120 days

次要结局

  • Change in fatty acid levels in plasma(Baseline, 120 days)
  • Stability of methylation of promoter region of FADS2 gene(Baseline, 120 days)

研究者

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

Carol Cheatham, PhD

Assistant Professor of Psychology

University of North Carolina, Chapel Hill

研究点 (2)

Loading locations...

相似试验