Effect of Daily Yogurt Smoothies on Neurocognitive Function in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cognitive and Brain Responses to Yogurt Smoothie Intake
研究概览
简要总结
The proposed study will examine whether eating yogurt every day can improve brain and gut health in children. Prior research suggests that yogurt may support cognitive functions like self-control, but more studies are needed to confirm this. The study will follow 60 children from Central Pennsylvania, ages 8 to 10, who will be randomly assigned to drink either fruit juice (control group) or yogurt smoothies once or twice a day for four weeks.
Researchers will compare how different amounts of yogurt affect children's thinking skills (like memory and focus), brain activity, and gut bacteria. These changes will be measured through brain scans, computer-based thinking tasks, surveys, and stool samples. The study will also collect information about children's overall diet. The goal is to find out if yogurt can support healthy brain and gut development and to determine the right amount to include in a child's daily diet. Results will help guide future research on how nutrition supports children's health.
详细描述
This study is a randomized, between group, dose-response study. Children will be randomly assigned to either receive the control (fruit juice) or a dosage of the experimental yogurt smoothie (1x versus 2x daily) for 4 weeks. Blinding will be established so that researchers do not know which group children are assigned to and families do not know which smoothie is expected to change outcomes. Children will be advised to minimize additional consumption of fermented dairy during the intervention (besides the yogurt provided).
Outcomes will be measured at 2 timepoints: immediately before and immediately following the exposure (2 laboratory visits). The visits will take place around 4 weeks apart. In each visit, child participants will undergo a series of tasks, including a Stop Signal Task (SST), a Flanker Task, the Wide Range Assessment of Memory and Learning (WRAML3), the Delis-Kaplan Executive Function System (D-KEFS), the Weschler Abbreviated Scale of Intelligence (WASI-II), and the N-back test. During the N-back test, participants will wear an fNIRS cap to measure and record localized brain activity. Skin carotenoid levels will also be measured using the Veggie Meter. Throughout each visit, the parent participant will complete a series of questionnaires that assess family demographics, home food security, child behavior and temperament, child executive function, family food behaviors, child pubertal development, and beverage consumption frequency. Between the two visits, along with the consumption of the juice or yogurt each day, child participants will complete a weekly food log survey. Parent participants will also complete weekly surveys that assess home food inventory, food and beverage consumption practices, and child behavior. Additionally, parent participants will be asked to collect a fecal sample from their child 1-7 nights before each visit with a provided fecal sample collection kit.
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
- Single (Outcomes Assessor)
盲法说明
In this study, Research Assistants (RAs) responsible for administering tasks and collecting data (e.g., behavioral assessments, fNIRS recordings) are blinded to group assignment.
入排标准
- 年龄范围
- 7 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children should be of good health, without presence of any metabolic, gastrointestinal, or developmental disorders (e.g., ADHD, autism, etc.).
- •Children should not be taking medications that impact appetite or cognitive function.
- •Children must be willing to consume and report liking the fermented dairy smoothie.
- •Children should be between the ages of 7-9 years-old at enrollment.
- •Children should speak English fluently.
排除标准
- •They are not within the age requirements (< 7 years-old or > 9 years-old) at baseline.
- •They have known emotional or cognitive delays, so that we can be assured that they understand the procedures.
- •They do not speak English fluently.
- •They have parentally reported medical problems that affect the digestive system or ability to eat yogurt (e.g., lactose intolerance, food allergies, Crohn's disease, Celiac disease, Esophagitis) and/or are taking a prescription medication that may affect appetite (e.g., Ritalin, methylphenidate, Adderall XR, Concerta, Vyvanse, etc.).
- •They are not from families of rural communities (assessed by National Center for Education Statistics local classifications).
- •Their parent is unable to attend the study visits.
研究组 & 干预措施
1 daily yogurt smoothie
Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and ~70 kcal)
干预措施: Yogurt Smoothie (1 per day) (Dietary Supplement)
2 daily yogurt smoothies
Children will have the experimental doses of yogurt smoothies (2x daily) for 4 weeks. (186 mL and ~140 kcal)
干预措施: Yogurt Smoothie (2 per day) (Dietary Supplement)
daily fruit juice control
Children will have the fruit juice control (1 juice per day) for 4 weeks. (isocaloric fruit juice ~140 kcal)
干预措施: Fruit Juice Control (Dietary Supplement)
结局指标
主要结局
Cognitive and Brain Responses to Yogurt Smoothie Intake
时间窗: Baseline and up to average of 4 weeks
The investigators will use standardized cognitive tests and functional near-infrared spectroscopy (fNIRS) to assess the effects of nutritional beverages, on executive function and hippocampal-dependent memory in children.
Gut Microbiome and Executive Function Responses
时间窗: Baseline and up to average of 4 weeks
Fecal samples will be collected at multiple time points to analyze changes in the gut microbiome composition and metabolome. These changes will be correlated with improvements in child executive function (EF) and prefrontal cortex (PFC) activation.
Prefrontal Cortex Activation During Working Memory After Yogurt Smoothie Intake
时间窗: Baseline and up to average of 4 weeks
The investigators will use fNIRS to assess prefrontal cortex activation while children complete a working memory task, comparing the effects of nutritional beverages.
次要结局
- Amount of smoothies leftover(Baseline and up to average of 4 weeks)
- Change in Emotional Symptoms Score (SDQ)(Every week)
- Child anthropometrics(Baseline and up to average of 4 weeks)
- Dietary intake and quality(Assessed weekly)
- Pubertal stage(Pre-exposure)
- Measures of carotenoids(Baseline and up to average of 4 weeks)
- Incidence of Gastrointestinal Adverse Events(Every day)
- Acceptability of the Intervention(Every day)
研究者
Kathleen Loralee Keller
Professor in Nutritional Sciences
Penn State University