Interaction Between Milk and Yogurt and Gastrointestinal Hormone Response on Cognitive Performance in School-Aged Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Learning and short-term memory
研究概览
简要总结
The purpose of this study is to investigate the short-term effects of milk and yogurt of varying fat and protein content on cognitive performance in healthy children aged 9 - 14 years; and to provide insight into mechanisms by which dairy consumption may affect cognitive performance through gastrointestinal (GI) hormone responses. The investigators hypothesize that the consumption of dairy products, specifically their protein and fat components, will improve cognitive performance via its interaction with the gut-brain axis in children. Furthermore, the investigators hypothesize that all milk and yogurt products will enhance cognitive performance over 120- mins compared to snack skipping through its interaction with GI hormones, with a greater effect in higher fat containing milk and yogurt products.
详细描述
A randomized within-subject repeated measures experiment will be used to study the effect of milk and yogurt of varying fat content on cognitive performance and its interaction with GI hormones in children (9-14 years). Participants will consume milk [Experiment A] and yogurt [Experiment B] test treatments, followed by measures of cognitive performance, blood glucose and GI hormone biomarkers over 120-min. In Experiment A and B, participants will consume, in a random order on separate mornings, one of four test treatments: (1) Full-fat, (2) Low-Fat, (3) No-fat, and (4) Snack-skipping test treatments. Cognitive domains (learning and memory, spatial working memory, attention, processing speed, and executive function), gastrointestinal hormone response, and subjective emotions will be assessed at baseline (0-min), and 30-, 60-, and 120-min following treatment consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 是
入选标准
- •9 to 14 years of age;
- •Normal weight is defined as being between the 5th and 85th percentile for age and biological sex at birth according to the Centers for Disease Control growth reference charts
排除标准
- •Children with overweight/ obesity;
- •Children with food sensitivities or allergies to dairy, gluten or any foods used in the study;
- •Children with any diagnosed learning, emotional, or behavioural disabilities;
- •Children taking any medications that may influence cognitive performance.
研究组 & 干预措施
Fat-Free Milk Treatment
Test Treatment
干预措施: Fat-Free Milk (Other)
Low-Fat Milk Treatment
Test Treatment
干预措施: Low-Fat Milk (Other)
Full-Fat Milk Treatment
Test Treatment
干预措施: Full-fat Milk (Other)
Snack Skipping Treatment
Test Treatment
干预措施: Snack Skipping (Other)
Fat-Free Yogurt
Test Treatment
干预措施: Fat-Free Yogurt (Other)
Low-Fat Yogurt
Test Treatment
干预措施: Low-Fat Yogurt (Other)
Full-Fat Yogurt
Test Treatment
干预措施: Full-Fat Yogurt (Other)
结局指标
主要结局
Learning and short-term memory
时间窗: Immediate measured at 30-minutes post-treatment and delayed at 60- and 120-minutes post-treatment consumption
Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Learning and short-term memory will be assessed using an immediate and delayed Word Recall Test (accuracy).
Spatial working memory
时间窗: Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Spatial working memory will be assessed using the forward and backward versions of the Corsi Block Test (accuracy).
Sustained Attention
时间窗: Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Sustained attention and processing speed will be assessed using the Continuous Performance Test (CPT) (accuracy).
Executive Function
时间窗: Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption
Cognitive performance tests will be administered via a Dell tablet (Millisecond, Inquisit Web) and paper/pen. Executive function and selective attention will be assessed using the Flanker Task (accuracy)
次要结局
- Subjective mood and emotion(Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption)
- Gastrointestinal Hormone Response(Change from baseline (measured at 0-minutes before treatment) and at 30-minutes, 60-minutes and 120-minutes post-treatment consumption)
研究者
Nick Bellissimo, PhD
Professor
Toronto Metropolitan University