跳至主要内容
临床试验/NCT03321227
NCT03321227已完成不适用

Effect of Eggs and Egg Components on Cognitive Performance and Appetite in School-aged Children

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年4月9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
19
试验地点
2
主要终点
Change in memory from baseline

研究概览

简要总结

The purpose of the present study is to determine the effects of eggs and egg components on cognitive performance and appetite in children aged 9-14 years, as well as to identify the underlying physiological mechanisms in this relationship.

详细描述

Children will be asked to refrain from exercising the morning of their test day and inform researchers of any illness. Following a 12-hour overnight fast, children will consume a standardized breakfast of a cereal bar, fruit cup and orange juice at home (total 330 kcal). Children will be asked to avoid consumption of any other food, with the exception of water, until arrival at the laboratory 3 hours later.

At the laboratory, five treatments of: (a) 2 whole eggs, (b) 2 egg whites, (c) 2 egg yolks, (d) full fat yogurt isocaloric to the 2 whole eggs, and (e) snack skipping will be provided to children 9-14 years on separate days at least 7 days apart. Cognitive performance, subjective emotion/mood, and subjective appetite will be measured for 90-minutes following snack consumption (n=25). Cognitive performance assessments will include learning and memory, spatial memory, attention and processing speed, and executive functions. In a subgroup of individuals (n=10), glucose, insulin, incretin hormones (glucagon like peptide1(GLP1) and gastric inhibitory polypeptide (GIP)),dipeptidyl peptidase 4 (DPP4), amino acids, fatty acids, and choline will be measured for 90-minutes following snack consumption.

研究设计

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

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • be between 9 and 14 years of age
  • be healthy, and have been born at term
  • healthy body weight (between the 5th and 85th BMI percentile for age and gender)

排除标准

  • children with food sensitivities or allergies to eggs, egg-products, dairy and wheat
  • children with any diagnosed learning, emotional, or behavioral disabilities
  • children on medications that may influence cognitive performance

结局指标

主要结局

Change in memory from baseline

时间窗: 15, 30, 60, and 90 minutes

One of five word lists composed of 15 words will be audio-visually presented to children. The majority of the words will be one syllable, and four words in each list will be two syllables long. The list will be presented at baseline and the children will be asked to recall as many words as possible at each time-point. The list will be presented for 2.5 minutes, and children will have 2 minutes for both immediate and delayed recall.

Change in spatial working memory from baseline

时间窗: 0, 15, 30, 60, and 90 minutes

Assessed using a spatial pattern recognition test via the Membrain application. The test consists of a series of subtests where children will be presented a picture with patterns to study, and asked to identify a picture with the same pattern from a group of four images. This test will be at each time-point and takes approximately 1 minute to complete.

Change in attention from baseline

时间窗: 0, 15, 30, 60, and 90 minutes

The continuous performance task (CPT) will be completed via the Membrain application. During the CPT task, children will be given a sequence of two letters to identify; for example respond to the detection of the letter "X" only when it is preceded by the letter "A". This task will be at each time-point and will take 3 minutes total to complete.

Change in executive function from baseline

时间窗: 0, 15, 30, 60, and 90 minutes

The Stroop task will be completed via the Membrain application. Children will be presented with a list of words presented in colors that match the word (congruent, the word 'red' presented in red) or colors that do not match the word (incongruent, the word 'red' presented in blue). Children will be asked to identify the color of the word, not the word itself. The task is scored for the number of correct and incorrect colors identified, as well as total time to completion. This test will be at each time-point and will take 1 minute to complete.

次要结局

  • Change from baseline dipeptidyl peptidase 4 (DPP4)(0, 15, 30, 60, and 90 minutes)
  • Change from baseline glucagonlike peptide1 (GLP1)(0, 15, 30, 60, and 90 minutes)
  • Change from baseline mood(0, 15, 30, 60, and 90 minutes)
  • Change from baseline subjective appetite(0, 15, 30, 60, and 90 minutes)
  • Change from baseline cholecystokinin (CCK)(0, 15, 30, 60, and 90 minutes)
  • Change from baseline insulin(0, 15, 30, 60, and 90 minutes)
  • Change from baseline glycemic response(0, 15, 30, 60, and 90 minutes)
  • Change from baseline amino acids(0, 15, 30, 60, and 90 minutes)
  • Change from baseline fatty acids(0, 15, 30, 60, and 90 minutes)
  • Change from baseline choline(0, 15, 30, 60, and 90 minutes)

研究者

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

Nick Bellissimo

Associate Professor

Toronto Metropolitan University

研究点 (2)

Loading locations...

相似试验

Effect of Eggs and Egg Components on Cognitive... | 临床试验