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| Name | Class |
|---|---|
| National Dairy Council | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 daily yogurt smoothie | Experimental | Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and ~70 kcal) |
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| 2 daily yogurt smoothies | Experimental | Children will have the experimental doses of yogurt smoothies (2x daily) for 4 weeks. (186 mL and ~140 kcal) |
|
| daily fruit juice control | Active Comparator | Children will have the fruit juice control (1 juice per day) for 4 weeks. (isocaloric fruit juice ~140 kcal) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt Smoothie (1 per day) | Dietary Supplement | Children consume one yogurt smoothie per day for 4 weeks (93 mL and ~70 kcal). |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive and Brain Responses to Yogurt Smoothie Intake | 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. | Baseline and up to average of 4 weeks |
| Prefrontal Cortex Activation During Working Memory After Yogurt Smoothie Intake | The investigators will use fNIRS to assess prefrontal cortex activation while children complete a working memory task, comparing the effects of nutritional beverages. | Baseline and up to average of 4 weeks |
| Gut Microbiome and Executive Function Responses | 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. | Baseline and up to average of 4 weeks |
| Prefrontal Cortex Activation During Working Memory After Yogurt Smoothie Intake | Working memory will be measured using the WRAML3 (Wide Range Assessment of Memory and Learning, Third Edition). | Baseline and up to average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Child anthropometrics | Height and weight will be measured every week using a stadiometer scale. From these, BMI (Body Mass Index) will be calculated and converted to BMI z-score and BMI-for-age and sex percentile | Baseline and up to average of 4 weeks |
| Amount of smoothies consumed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen L Keller, Ph.D. | Contact | 814-863-2915 | klk37@psu.edu | |
| Alaina L Pearce, Ph.D. | Contact | 814-630-2120 | azp271@psu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen L Keller, Ph.D. | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Kitchen and Children's Eating Behavior Lab | State College | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27881393 | Background | English LK, Fearnbach SN, Wilson SJ, Fisher JO, Savage JS, Rolls BJ, Keller KL. Food portion size and energy density evoke different patterns of brain activation in children. Am J Clin Nutr. 2017 Feb;105(2):295-305. doi: 10.3945/ajcn.116.136903. Epub 2016 Nov 23. | |
| 30089279 | Background | Smith SR, Johnson ST, Oldman SM, Duffy VB. Pediatric Adapted Liking Survey: A Novel, Feasible and Reliable Dietary Screening in Clinical Practice. Caries Res. 2019;53(2):153-159. doi: 10.1159/000485467. Epub 2018 Aug 8. |
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In this study, Research Assistants (RAs) responsible for administering tasks and collecting data (e.g., behavioral assessments, fNIRS recordings) are blinded to group assignment.
| Yogurt Smoothie (2 per day) | Dietary Supplement | Children consume two yogurt smoothies per day for 4 weeks (186 mL and ~140 kcal). |
|
| Fruit Juice Control | Dietary Supplement | Children consume one fruit juice per day for 4 weeks (~140 kcal, isocaloric with 2 yogurt smoothie). |
|
Parents will complete a daily questionnaire to log consumption. |
| Baseline and up to average of 4 weeks |
| Change in Emotional Symptoms Score (SDQ) | Weekly parent-completed Strengths and Difficulties Questionnaire (SDQ) reporting emotional symptoms subscale, assessing 25 positive and negative behaviors | Every week |
| Dietary intake and quality | Dietary intake will be assessed using two 24-hour dietary recalls per week (one weekday and one weekend day), completed with parental assistance through the ASA24 (Automated Self-Administered 24-hour Dietary Assessment Tool). | Assessed weekly |
| Pubertal stage | Child Tanner stage will be reported by parents at baseline using the Tanner Staging Questionnaire (male or female). | Pre-exposure |
| Measures of carotenoids | The investigators will use a Veggie Meter. It's a device that non-invasively measures the amount of carotenoids in a person's skin, which serves as an indicator of their fruit and vegetable consumption. | Baseline and up to average of 4 weeks |
| Incidence of Gastrointestinal Adverse Events | Parents will complete a daily survey reporting the presence or absence of gastrointestinal symptoms (constipation, diarrhea, abdominal pain, bloating, nausea). Each symptom will be recorded as present/absent, and frequency will be assessed. | Every day |
| Acceptability of the Intervention | Parents will complete a daily survey rating the acceptability of the intervention. Acceptability will be assessed using a Likert scale (e.g., 1 = not acceptable, 5 = highly acceptable) | Every day |
| 29086502 | Background | Pearce AL, Mackey E, Cherry JBC, Olson A, You X, Magge SN, Mietus-Snyder M, Nadler EP, Vaidya CJ. Effect of Adolescent Bariatric Surgery on the Brain and Cognition: A Pilot Study. Obesity (Silver Spring). 2017 Nov;25(11):1852-1860. doi: 10.1002/oby.22013. |
| 26014476 | Background | Cravener TL, Schlechter H, Loeb KL, Radnitz C, Schwartz M, Zucker N, Finkelstein S, Wang YC, Rolls BJ, Keller KL. Feeding Strategies Derived from Behavioral Economics and Psychology Can Increase Vegetable Intake in Children as Part of a Home-Based Intervention: Results of a Pilot Study. J Acad Nutr Diet. 2015 Nov;115(11):1798-807. doi: 10.1016/j.jand.2015.03.024. Epub 2015 May 23. |