Actively Recruiting
A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-03
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the development of neural flexibility, measured by MRI, as an indicator of cognitive flexibility in Chinese toddlers aged 32 to 42 months. The study also evaluates executive functions such as inhibition, shifting attention, emotional control, working memory, and planning using the Global Executive Composite score from a standardized rating scale. This research aims to better understand brain development and cognitive abilities during early childhood. Participants are divided into two groups based on their daily milk consumption: one group receives S-26 GOLD or ULTIMA GUM formula, while the other consumes cow's milk. Parents continue feeding their children these milk products throughout the study, and information about milk consumption is collected starting up to two months before and during the study period. The brain is examined using MRI, a safe and non-invasive imaging technology. During the study, toddlers undergo MRI scans and assessments of brain structure and function at the start and again at 42 months of age. Researchers also evaluate cognitive flexibility, behavior, curiosity, sleep quality, home environment, feeding practices, and fecal microbiota composition over time. Parents provide information through interviews, and the child's development and school readiness are monitored. The study runs from baseline through 42 months of age, with additional home environment data collected at 8 months after baseline.
CONDITIONS
Brief Title
A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from parent or legal representative
- Full-term birth at 37 weeks or later with birth weight of at least 2.5 kg
- Typically developing children aged between 32 and 34 months at enrollment
- Neurotypical development confirmed by interview
- No major risk factors for learning, neurologic, or psychiatric disorders in child or first degree relatives
- For S-26 GOLD/ULTIMA GUM group: daily consumption of formula for last 60 days and willingness to continue during study
- For cow's milk group: daily consumption of cow's milk for last 60 days and willingness to continue during study
You will not qualify if you...
- Birth delayed beyond 41 weeks gestation
- Birth weight under 2500 g or below 10th percentile, or above 90th percentile
- History of neurological, psychiatric, or developmental disorders in child
- History of diagnosed neurological, psychiatric, or developmental disorders in parents or siblings
- In utero exposure to alcohol abuse or illicit substances
- Multiple birth (e.g., twins or more)
- Complicated pregnancy such as preeclampsia or gestational diabetes
- Clinically significant abnormal screening laboratory values or studies as judged by investigator (e.g., metabolic diseases, neonatal bilirubin abnormalities)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo MRI scans and assessments to measure neural flexibility and executive functions at baseline.
1 visit (in-person)
Duration - 42 months
Participants are observed over time with repeated assessments of brain structure, function, cognitive flexibility, behavior, feeding practices, and environment to track development.
2 visits (at baseline and 42 months after baseline), plus 1 additional visit at 8 months after baseline for home environment assessment
Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
J
Joyce Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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