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临床试验/NCT03951883
NCT03951883已完成不适用

Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?

Texas Tech University4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
4
主要终点
Comparison of functional activity during Eriksen-Flanker Task

研究概览

简要总结

Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 13-19 years.
  • Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.

排除标准

  • Participants unable or unwilling to provide informed consent.
  • Participants with motor, visual or hearing impairment.
  • Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
  • Participants with history of psychiatric hospitalization.
  • Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
  • Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
  • History of liver or kidney disease, cardiovascular disease, hematologic disease, metabolic disease, Epilepsy (or other seizure disorder) or malignant tumor
  • Currently taking (or have taken in the past 4 weeks) any anti-anxiolytic, anti-epileptic, or anti-depression medications
  • Currently taking (or have taken in the past 4 weeks) any proton pump inhibitor medications
  • History of any cognitive disorder, medical and/or psychological conditions and/or medications affecting cognition
  • Participants with contraindications for MRI scanning.
  • aneurism clips
  • any implanted medical devices (pacemaker, neurostimulator)
  • known pregnancy
  • shrapnel in body or any injury to eye involving metal
  • any ferrous metal in body

结局指标

主要结局

Comparison of functional activity during Eriksen-Flanker Task

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention)

Changes in regional brain activation during an fMRI scan.

Comparison of grey matter anatomical change

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention)

Grey density as measured by MRI

Comparison of white matter connectivity change

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention)

White matter connectivity as measured by diffusion tensor imaging

Comparison of Eriksen-Flanker Task performance change

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention)

Eriksen-Flanker task performance compared using the drift diffusion model

Comparison of cognitive battery performance change

时间窗: Baseline (pre-intervention) and 12 weeks (post-intervention)

Cognitive performance as measured by stop signal reaction time task

次要结局

未报告次要终点

研究者

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

Martin Binks

Associate Professor

Texas Tech University

研究点 (4)

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