Growth & DevelopmentNCT04916652
A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
An observational study of Growth & Development and Brain, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old). Read more about this study
- Who is it for?
- Ages 32 to 34 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth & Development, Brain
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2024to Feb 2027
- Phase
- Observational
- 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 32 to 34 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy normal developing Chinese toddlers; minimum number of subjects with successful MRI scans at enrolment and age 42 months: N=60 (≈ 30 fed on S-26 GOLD/ ULTIMA growing-up milk (GUM) and ≈30 fed on cows' milk) with key inclusion as daily consumption of the S-26 GUM or cow's milk for the last 60 days (2 mo).
Who may be able to join
- Written informed consent has been obtained from the parent/legally acceptable representative.
- Full-term birth (≥ 37 weeks and ≥ 2.5kg)
- Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment
- Neurotypical development as assessed by interview
- No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview [defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)].
- Dietary requirement detailed below:
Show all 10Show fewer
- S-26 GOLD or ULTIMA GUM--fed group:
- Daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) II. Desire of the parent to continue feeding GUM during the course of the study
- Cow's milk-fed group:
- Daily consumption of cow's milk or for the last 60 days (2 months) II. Desire of the parent to continue feeding cow's milk during the course of the study
Who cannot join
- Delayed birth ( > 41 weeks gestation) as reported in medical record
- Birth Weight < 2500 g or small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight above the 90th percentile) as reported in medical record
- History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview
- History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview
- In utero exposure to alcohol abuse or illicit substances as defined as diagnosis of current substance use disorder in the biological mother and guidelines set by the American College of Obstetricians and Gynecologists and the Royal College of Physicians
- Multiple birth as reported in medical record
- Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview/ medical record
- Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator (e.g., metabolic disease screening, neonatal bilirubin)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality
Fan Jiang
About this study
The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).
Read the detailed description
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
- Conditions
- Growth & Development, Brain
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
MRI is a safe, non-invasive, cutting edge imaging technology widely used to study the human brain both internationally (NIH connectome project) and in China (China Brain Project). The Baby Connectome Project (BCP) led by NIH scientists has begun data collection on the structural and functional brain development among American infants (Howell, Styner et al. 2019).
| Study group | Role | What they receive |
|---|---|---|
| S-26 GOLD/ULTIMA GUM-fed group: | Parent(s) to continue feeding their child S-26 GOLD or ULTIMA GUM during the course of the study.
We will collect information from parents on the S-26 GOLD/ ULTIMA GUM for a maximum of 2 months prior to the study start and during the course of the study. Receives: Radiation: MRI | |
| Cow's milk-fed group: | Parent(s) to continue feeding their child cow's milk during the course of the study.
We will collect information from parents on the cow's milk consumed for a maximum of 2 months prior to the study start and during the course of the study. Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural flexibility
MRI-derived neural flexibility associated with cognitive flexibility (including anterior cingulate cortex, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, anterior insula, interior frontal junction, superior parietal lobule, precuneus, intraparietal sulcus, and temporoparietal junction)
Measured: at baseline and 42 months after baseline
Global Executive Composite (GEC) score
executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale
Measured: at baseline and 42 months of age
Secondary outcomes (16)
Brain structure (brain regions volume)
Brain structure (brain regions volume) measured using MRI, including the hippocampal
Measured: at baseline and 42 months of age
Brain structure (cortical surface area)
Brain structure (cortical surface area) measured using MRI
Measured: at baseline and 42 months of age
Brain structure (cortical thickness)
Brain structure (cortical thickness) measured using MRI
Measured: at baseline and 42 months of age
Brain structure (myelination)
Brain structure (myelination) measured using MRI
Measured: at baseline and 42 months of age
Brain function (network topologies)
Brain functional network topologies of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI
Measured: at baseline and 42 months of age
Brain function (connection strengths)
Brain functional connection strengths of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI
Measured: at baseline and 42 months of age
Cognitive flexibility
Using the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) parent-completed questionnaire
Measured: at baseline and 42 months of age
Children development
Verbal Comprehension, Visual Spatial, Working Memory, and IQ using Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV)
Measured: at baseline and 42 months of age
School readiness
Using Early Human Capability Index (eHCI)
Measured: at 42 months of age
Children behavior (for toddlers)
Using the Early Childhood Behavioral Questionnaire (ECBQ)
Measured: at baseline and 42 months of age
Curiosity
Using the Curiosity Questionnaire
Measured: at baseline and 42 months of age
Sleep quality
Sleep quality, duration and efficiency (total sleep time / duration of sleep episode *100) computed using the Brief Infant Sleep Questionnaire (BISQ). In addition, an actigraphy in combination with a sleep diary will be used during home period and their relationship will indicate the sleep quality
Measured: at baseline and 42 months of age
Home environment
Using validated Child Feeding Practice Questionnaire. In addition, to complete the feeding and adverse events calendar monthly during home period
Measured: at baseline and 8 months after baseline
Feeding practice
Using the Early Feeding Practice Questionnaire. In addition, the feeding and adverse events calendar monthly during home period
Measured: at baseline and 42 months of age
Fecal microbiota composition
Measured via the shotgun metagenomics sequencing for species composition and functional pathways through stool samples collected
Measured: at baseline and 42 months of age
Cognitive flexibility
Using the Dimensional Change Card Sort (DCCS) task
Measured: at baseline and 42 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 Apr 2024
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth & DevelopmentStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fan Jiang, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916652
- Sponsor's protocol ID
- 20.02.INF
- Status last verified
- Nov 2025
- First submitted
- 29 Oct 2020
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
- ClinicalTrials.gov ID
- NCT04916652
- Acronym / sponsor ID
- 20.02.INF
- Conditions
- Growth & Development, Brain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Jun 2021 (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 overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).
Detailed description
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-26 GOLD/ULTIMA GUM-fed group: | – | Radiation: MRIParent(s) to continue feeding their child S-26 GOLD or ULTIMA GUM during the course of the study. We will collect information from parents on the S-26 GOLD/ ULTIMA GUM for a maximum of 2 months prior to the study start and during the course of the study. |
| Cow's milk-fed group: | – | Radiation: MRIParent(s) to continue feeding their child cow's milk during the course of the study. We will collect information from parents on the cow's milk consumed for a maximum of 2 months prior to the study start and during the course of the study. |
Who may qualify
- Ages
- 32 to 34 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy normal developing Chinese toddlers; minimum number of subjects with successful MRI scans at enrolment and age 42 months: N=60 (≈ 30 fed on S-26 GOLD/ ULTIMA growing-up milk (GUM) and ≈30 fed on cows' milk) with key inclusion as daily consumption of the S-26 GUM or cow's milk for the last 60 days (2 mo).
Key inclusion criteria (10 listed)
- Written informed consent has been obtained from the parent/legally acceptable representative.
- Full-term birth (≥ 37 weeks and ≥ 2.5kg)
- Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment
- Neurotypical development as assessed by interview
- No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview [defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)].
Key exclusion criteria (8 listed)
- Delayed birth ( > 41 weeks gestation) as reported in medical record
- Birth Weight < 2500 g or small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight above the 90th percentile) as reported in medical record
- History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview
- History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview
- In utero exposure to alcohol abuse or illicit substances as defined as diagnosis of current substance use disorder in the biological mother and guidelines set by the American College of Obstetricians and Gynecologists and the Royal College of Physicians
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 |
|---|---|---|
| MRIMRI is a safe, non-invasive, cutting edge imaging technology widely used to study the human brain both internationally (NIH connectome project) and in China (China Brain Project). The Baby Connectome Project (BCP) led by NIH scientists has begun data collection on the structural and functional brain development among American infants (Howell, Styner et al. 2019). | Radiation | Cow's milk-fed group:, S-26 GOLD/ULTIMA GUM-fed group: |
Primary outcome
Neural flexibility
Time frame: at baseline and 42 months after baseline
MRI-derived neural flexibility associated with cognitive flexibility (including anterior cingulate cortex, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, anterior insula, interior frontal junction, superior parietal lobule, precuneus, intraparietal sulcus, and temporoparietal junction)
Global Executive Composite (GEC) score
Time frame: at baseline and 42 months of age
executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale
16 secondary outcomes
Brain structure (brain regions volume)
Time frame: at baseline and 42 months of age
Brain structure (cortical surface area)
Time frame: at baseline and 42 months of age
Brain structure (cortical thickness)
Time frame: at baseline and 42 months of age
Brain structure (myelination)
Time frame: at baseline and 42 months of age
Brain function (network topologies)
Time frame: at baseline and 42 months of age
Brain function (connection strengths)
Time frame: at baseline and 42 months of age
Cognitive flexibility
Time frame: at baseline and 42 months of age
Children development
Time frame: at baseline and 42 months of age
School readiness
Time frame: at 42 months of age
Children behavior (for toddlers)
Time frame: at baseline and 42 months of age
Curiosity
Time frame: at baseline and 42 months of age
Sleep quality
Time frame: at baseline and 42 months of age
Home environment
Time frame: at baseline and 8 months after baseline
Feeding practice
Time frame: at baseline and 42 months of age
Fecal microbiota composition
Time frame: at baseline and 42 months of age
Cognitive flexibility
Time frame: at baseline and 42 months of age
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 3 Dec 2025.
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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.
Fan Jiang principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth & Development and Brain, run by Société des Produits Nestlé (SPN) at 1 site in China.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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 China. 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 Joyce Li (+86 15810125435, joyce.li@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural flexibility (time frame: at baseline and 42 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025.