A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers

NCT04916652 | Recruiting

• 1 other identifier: 20.02.INF
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Growth & Development; Brain

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  at baseline and 42 months of age

Secondary Outcomes (16)

• Brain structure (brain regions volume)

  at baseline and 42 months of age

• Brain structure (cortical surface area)

  at baseline and 42 months of age

• Brain structure (cortical thickness)

  at baseline and 42 months of age

• Brain structure (myelination)

  at baseline and 42 months of age

• Brain function (network topologies)

  at baseline and 42 months of age

Other Outcomes (7)

• Gastrointestinal tolerance (for toddlers)

  at baseline and 42 months of age

• Anthropometry (weight in grams)

  at baseline and 42 months of age

• Anthropometry (body length in centimeters)

  at baseline and 42 months of age

Study Arms (2)

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.

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.

Radiation: MRI

Interventions

MRI RADIATION

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).

Cow's milk-fed group:; S-26 GOLD/ULTIMA GUM-fed group:

Eligibility Criteria

• Age: 32 Months - 34 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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:
• S-26 GOLD or ULTIMA GUM--fed group:
• I. 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:
• I. 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Fan Jiang

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce Li

CONTACT

+86 15810125435; joyce.li@rd.nestle.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: June 7, 2021
• Study Start: April 6, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CN (1)