The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in Cognitive Control at 15 minutes Postprandial
研究概览
简要总结
The aim of this study is to investigate the acute effects of ingestion of carbohydrates - with different glycemic profiles - on cognitive function among preadolescent children (i.e., 9-10 years).
详细描述
Regular breakfast consumption is linked to improved cognitive performance in school-aged children. However, the acute benefits of defined nutrient consumption on brain and cognitive health are not well understood, particularly in preadolescent children. One factor that may relate to brain health and learning in children is the contribution of carbohydrates to the digestion rate of a meal (and associated effects on post-prandial glycemia).
The effects of differentially absorbed carbohydrates on brain and cognition are unknown, especially when ingested via a fortified nutritional beverage providing a balanced array of nutrients. The aim of this study is to investigate the acute, transient effect of nutrient supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10 years).
Participants will be randomized to receive one of three treatment nutritional formulations containing carbohydrates with varying absorption rates along with a non-caloric placebo. Participants will perform a cognitive battery in the fasted condition, shortly after treatment ingestion, and an hour after ingestion. Group differences in performance will be contrasted to assess the effects of different carbohydrate types on children's cognitive function following an overnight fast.
Findings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental/guardian consent.
- •Participants must be between the ages of 9-10 years old at the time of testing age
- •Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- •Participants must have an IQ > 85 (IQ < 85).
排除标准
- •Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, and dependence upon a wheelchair/walking aid, and ADHD Rating Scale score below 85%).
- •Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
- •Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
- •Lactose intolerance
- •Allergies to milk and/or soy
- •Adherence to a strict vegan diet
研究组 & 干预措施
SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.
干预措施: SLOW Carbohydrate (Other)
MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.
干预措施: MEDIUM Carbohydrate (Other)
FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.
干预措施: FAST Carbohydrate (Other)
Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
干预措施: SLOW Carbohydrate (Other)
Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
干预措施: MEDIUM Carbohydrate (Other)
Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
干预措施: FAST Carbohydrate (Other)
结局指标
主要结局
Change in Cognitive Control at 15 minutes Postprandial
时间窗: 15 minutes Postprandial
Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 15 minutes and baseline/fasted (within 2 hours of wake-time) performance.
Change in Cognitive Control at 70 minutes Postprandial
时间窗: 70 minutes Postprandial
Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 70 minutes and baseline/fasted (within 2 hours of wake-time).
次要结局
- Change in Relational Memory at 30 minutes Postprandial(30 minutes Postprandial)
- Change in Relational Memory at 85 minutes Postprandial(85 minutes Postprandial)