Executive Functions (EF)SPARKNCT07195474
Smoothie Program for Achieving and Resilient Kids
A study testing Yogurt Smoothie (1 per day) and Yogurt Smoothie (2 per day) in people with Executive Functions (EF) and Microbiome, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Functions (EF), Microbiome, Dietary Quality
- What is being tested?
- Yogurt Smoothie (1 per day) and Yogurt Smoothie (2 per day)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Metabolic Kitchen and Children's Eating Behavior Lab
State College, Pennsylvania, 16802
Kathleen L Keller, Ph.D.
Alaina L Pearce, Ph.D
About this study
Official title: Effect of Daily Yogurt Smoothies on Neurocognitive Function in Children
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.
Read the 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 1-7 nights before each visit with a provided fecal sample collection kit.
- Conditions
- Executive Functions (EF), Microbiome, Dietary Quality
- Being tested
- Yogurt Smoothie (1 per day), Yogurt Smoothie (2 per day), Fruit Juice Control
- Keywords
- Cognitive Function, daily yogurt smoothies intake, gut and brain health, hippocampal-dependent memory, dose-dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ControlDietary supplement
Children consume one fruit juice per day for 4 weeks (~140 kcal, isocaloric with 2 yogurt smoothie).
| Study group | Role | What they receive |
|---|---|---|
| 1 daily yogurt smoothie | Experimental | Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and ~70 kcal) Receives: 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) Receives: 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) Receives: Dietary Supplement: Fruit Juice Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and up to average of 4 weeks
Secondary outcomes (8)
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
Measured: Baseline and up to average of 4 weeks
Amount of smoothies consumed
Parents will complete a daily questionnaire to log consumption.
Measured: 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
Measured: 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).
Measured: Assessed weekly
Pubertal stage
Child Tanner stage will be reported by parents at baseline using the Tanner Staging Questionnaire (male or female).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Every day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startMay 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Executive Functions (EF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Dairy Council
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen L Keller, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195474
- Sponsor's protocol ID
- STUDY00027677
- Acronym
- SPARK
- Status last verified
- May 2026
- First submitted
- 18 Aug 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27881393Smith 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.
PubMed 30089279Pearce 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.
PubMed 29086502Cravener 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.
PubMed 26014476
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Yogurt Smoothies on Neurocognitive Function in Children
- ClinicalTrials.gov ID
- NCT07195474
- Acronym / sponsor ID
- SPARK / STUDY00027677
- Conditions
- Executive Functions (EF), Microbiome, Dietary Quality
- Keywords
- Cognitive Function, daily yogurt smoothies intake, gut and brain health, hippocampal-dependent memory, dose-dependent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Dairy Council
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1-7 nights before each visit with a provided fecal sample collection kit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 daily yogurt smoothie | Experimental | Dietary Supplement: Yogurt Smoothie (1 per day)Children will have the experimental doses of yogurt smoothies (1x daily) for 4 weeks. (93 mL and ~70 kcal) |
| 2 daily yogurt smoothies | Experimental | Dietary Supplement: Yogurt Smoothie (2 per day)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 | Dietary Supplement: Fruit Juice ControlChildren will have the fruit juice control (1 juice per day) for 4 weeks. (isocaloric fruit juice ~140 kcal) |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yogurt Smoothie (1 per day)Children consume one yogurt smoothie per day for 4 weeks (93 mL and ~70 kcal). | Dietary supplement | 1 daily yogurt smoothie |
| Yogurt Smoothie (2 per day)Children consume two yogurt smoothies per day for 4 weeks (186 mL and ~140 kcal). | Dietary supplement | 2 daily yogurt smoothies |
| Fruit Juice ControlChildren consume one fruit juice per day for 4 weeks (~140 kcal, isocaloric with 2 yogurt smoothie). | Dietary supplement | daily fruit juice control |
Primary outcome
Cognitive and Brain Responses to Yogurt Smoothie Intake
Time frame: Baseline and up to average of 4 weeks
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.
Prefrontal Cortex Activation During Working Memory After Yogurt Smoothie Intake
Time frame: Baseline and up to average of 4 weeks
The investigators will use fNIRS to assess prefrontal cortex activation while children complete a working memory task, comparing the effects of nutritional beverages.
Gut Microbiome and Executive Function Responses
Time frame: Baseline and up to average of 4 weeks
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.
Prefrontal Cortex Activation During Working Memory After Yogurt Smoothie Intake
Time frame: Baseline and up to average of 4 weeks
Working memory will be measured using the WRAML3 (Wide Range Assessment of Memory and Learning, Third Edition).
8 secondary outcomes
Child anthropometrics
Time frame: Baseline and up to average of 4 weeks
Amount of smoothies consumed
Time frame: Baseline and up to average of 4 weeks
Change in Emotional Symptoms Score (SDQ)
Time frame: Every week
Dietary intake and quality
Time frame: Assessed weekly
Pubertal stage
Time frame: Pre-exposure
Measures of carotenoids
Time frame: Baseline and up to average of 4 weeks
Incidence of Gastrointestinal Adverse Events
Time frame: Every day
Acceptability of the Intervention
Time frame: Every day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 27881393English 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.
- Background: PubMed 30089279Smith 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.
- Background: PubMed 29086502Pearce 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.
- Background: PubMed 26014476Cravener 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen L Keller, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt Smoothie (1 per day) and Yogurt Smoothie (2 per day) in people with Executive Functions (EF) and Microbiome, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen L Keller, Ph.D. (814-863-2915, klk37@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive and Brain Responses to Yogurt Smoothie Intake (time frame: Baseline and up to average of 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07195474, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.