Trials / Not Yet Recruiting
Not Yet RecruitingNCT07195474
Smoothie Program for Achieving and Resilient Kids
Effect of Daily Yogurt Smoothies on Neurocognitive Function in Children
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Penn State University · Academic / Other
- Sex
- All
- Age
- 7 Years – 9 Years
- Healthy volunteers
- Accepted
Summary
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 7 to 9, 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.
Detailed description
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 1-2 nights before each visit with a provided fecal sample collection kit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Yogurt Smoothie (1 per day) | Children consume one yogurt smoothie per day for 4 weeks (93 mL and \~70 kcal). |
| DIETARY_SUPPLEMENT | Yogurt Smoothie (2 per day) | Children consume two yogurt smoothies per day for 4 weeks (186 mL and \~140 kcal). |
| DIETARY_SUPPLEMENT | Fruit Juice Control | Children consume one fruit juice per day for 4 weeks (\~140 kcal, isocaloric with 2 yogurt smoothie). |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-09-01
- Completion
- 2028-09-01
- First posted
- 2025-09-26
- Last updated
- 2025-09-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07195474. Inclusion in this directory is not an endorsement.