Smoothie Program for Achieving and Resilient Kids

ConditionsExecutive Functions (EF)Microbiome Dietary Quality

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-9

SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

Yogurt Smoothie (1 per day)
Dietary supplement
Children consume one yogurt smoothie per day for 4 weeks (93 mL and \~70 kcal).
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).

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: 1 daily yogurt smoothieExperimental treatment 1 intervention

Group B: 2 daily yogurt smoothiesExperimental treatment 1 intervention

Group C: daily fruit juice controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame