Smoothie Program for Achieving and Resilient Kids

NCT07195474 | Not Yet Recruiting

• 1 other identifier: STUDY00027677
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Executive Functions (EF); Microbiome; Dietary Quality

Keywords

Cognitive Function; daily yogurt smoothies intake; gut and brain health; hippocampal-dependent memory; dose-dependent

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Child anthropometrics

  Baseline and up to average of 4 weeks

• Amount of smoothies leftover

  Baseline and up to average of 4 weeks

• Change in Emotional Symptoms Score (SDQ)

  Every week

• Dietary intake and quality

  Assessed weekly

• Pubertal stage

  Pre-exposure

Study Arms (3)

1 daily yogurt smoothie

EXPERIMENTAL

Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and \~70 kcal)

Dietary Supplement: Yogurt Smoothie (1 per day)

2 daily yogurt smoothies

EXPERIMENTAL

Children will have the experimental doses of yogurt smoothies (2x daily) for 4 weeks. (186 mL and \~140 kcal)

Dietary Supplement: Yogurt Smoothie (2 per day)

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)

Dietary Supplement: Fruit Juice Control

Interventions

Yogurt Smoothie (1 per day) DIETARY_SUPPLEMENT

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

1 daily yogurt smoothie

Yogurt Smoothie (2 per day) DIETARY_SUPPLEMENT

Children consume two yogurt smoothies per day for 4 weeks (186 mL and \~140 kcal).

2 daily yogurt smoothies

Fruit Juice Control DIETARY_SUPPLEMENT

Children consume one fruit juice per day for 4 weeks (\~140 kcal, isocaloric with 2 yogurt smoothie).

daily fruit juice control

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• National Dairy Council: collaborator

Study Sites (1)

Metabolic Kitchen and Children's Eating Behavior Lab

State College, Pennsylvania, 16802, United States

Location

Related Publications (4)

• Drucker H, Wolcott RB. Gingival tissue management with Class V restorations. J Am Acad Gold Foil Oper. 1970 Apr;13(1):34-8. No abstract available.

  PMID: 5267299 BACKGROUND

• Steiger E. Home parenteral nutrition. Components, application, and complications. Postgrad Med. 1984 May;75(6):95-102. doi: 10.1080/00325481.1984.11716310.

  PMID: 6425815 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.

  PMID: 29086502 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.

  PMID: 26014476 BACKGROUND

Study Officials

• Kathleen L Keller, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen L Keller, Ph.D.

CONTACT

814-863-2915; klk37@psu.edu

Alaina L Pearce, Ph.D.

CONTACT

814-630-2120; azp271@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, Research Assistants (RAs) responsible for administering tasks and collecting data (e.g., behavioral assessments, fNIRS recordings) are blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Nutritional Sciences

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 26, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)