A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Quality of Memory and Attention based on results using CDR System
研究概览
简要总结
The objective of this study is to test the effects of breakfast on cognitive processing ability in children.
详细描述
Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
- •Provision of assent by subject
- •Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators
排除标准
- •Diagnosis of attention deficit disorder, with or without hyperactivity
- •A diagnosis of diabetes mellitus
- •Acute illness or use of antibiotics within 5 days of visit
- •Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
- •Known sensitivity or allergy to any ingredients of the study product
- •Use of any psychotropic medication within 4 weeks
- •Subject did not previously participate in an earlier trial with the same study products
- •Exposure to investigational agent within 30 days.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
研究组 & 干预措施
breakfast cereal
breakfast cereal and milk
干预措施: breakfast cereal (Other)
water
water
干预措施: water (Other)
结局指标
主要结局
Quality of Memory and Attention based on results using CDR System
时间窗: 4 hours following breakfast
次要结局
- Speed of Memory and Attention based on results using CDR System(4 hours following breakfast)