Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2026-03-31
2028-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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1 daily yogurt smoothie
Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and \~70 kcal)
Yogurt Smoothie (1 per day)
Children consume one yogurt smoothie per day for 4 weeks (93 mL and \~70 kcal).
2 daily yogurt smoothies
Children will have the experimental doses of yogurt smoothies (2x daily) for 4 weeks. (186 mL and \~140 kcal)
Yogurt Smoothie (2 per day)
Children consume two yogurt smoothies per day for 4 weeks (186 mL and \~140 kcal).
daily fruit juice control
Children will have the fruit juice control (1 juice per day) for 4 weeks. (isocaloric fruit juice \~140 kcal)
Fruit Juice Control
Children consume one fruit juice per day for 4 weeks (\~140 kcal, isocaloric with 2 yogurt smoothie).
Interventions
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Yogurt Smoothie (1 per day)
Children consume one yogurt smoothie per day for 4 weeks (93 mL and \~70 kcal).
Yogurt Smoothie (2 per day)
Children consume two yogurt smoothies per day for 4 weeks (186 mL and \~140 kcal).
Fruit Juice Control
Children consume one fruit juice per day for 4 weeks (\~140 kcal, isocaloric with 2 yogurt smoothie).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
7 Years
9 Years
ALL
Yes
Sponsors
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National Dairy Council
OTHER
Penn State University
OTHER
Responsible Party
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Kathleen Loralee Keller
Professor in Nutritional Sciences
Principal Investigators
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Kathleen L Keller, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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Metabolic Kitchen and Children's Eating Behavior Lab
State College, Pennsylvania, United States
Countries
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Central Contacts
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References
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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.
Steiger E. Home parenteral nutrition. Components, application, and complications. Postgrad Med. 1984 May;75(6):95-102. doi: 10.1080/00325481.1984.11716310.
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.
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.
Other Identifiers
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STUDY00027677
Identifier Type: -
Identifier Source: org_study_id
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