Clinical trial NCT03111927: Infant Nutrition and Brain Development
Official title: The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Infant Development
Keywords: Nutrition, Brain Development, Cognition, Heathy Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 189
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, double blind, randomized, controlled, parallel group clinical trial, consisting of 2 arms randomized to receive either the investigational or the control product, and a nonrandomized, nonblinded arm of fully breastfed infants.

3 groups: enriched level of myelin-relevant nutrients in an Infant Formula, standard level of myelin-relevant nutrients in an Infant Formula, breastfed infants
Primary purpose: BASIC_SCIENCE

Brief summary: Research study on the role of early life nutrition on brain and cognitive development during infancy and early childhood. Two blends of myelin-relevant nutrients at different levels were compared and a breastfed group was considered as epidemiological reference.

Detailed description: This nutritional intervention study involved assessments in both the mother and her infant. The mother was asked to complete self-report questionnaires and to undergo a brief cognitive assessment. If the mother was not breastfeeding, a study product was provided and was consumed by the infant daily up to 12 months of life. The study also involved magnetic resonance imaging (MRI) brain scans of the infant's brain while asleep as well as evaluation of cognitive outcomes, including general cognitive development, and social-emotional development.

Once all trial subjects completed the 6-month timepoint (intervention part), an inferential statistical analysis of all data up to 6 months was performed.

Product codes (blinding) were broken to compare groups and an appropriate operational framework was put in place to maintain the individual assignment unknown to the Sponsor and Sites until the end of the trial.

Eligibility criteria: Inclusion Criteria:

* Term infants (≥ 37 weeks)
* Neuro typical development
* No major risk factors for learning, neurologic, or psychiatric disorder
* Between 2 weeks and maximum 5 weeks of age. If mother is breastfeeding she can choose the infant begin the trial prior 2 weeks.
* Parents/legal guardians willing and able to complete the informed consent process

Exclusion Criteria:

* Delayed birth (\> 41 weeks gestation)
* Birth Weight \< 2000 g or small for gestation age or large for gestational age
* Psychopharmacological treatment of mother using prohibited medications during pregnancy
* In utero exposure to alcohol abuse or illicit substances as per the American College of Obstetricians and Gynecologists
* Abnormalities on fetal ultrasound
* Complicated pregnancy
* Neonatal intensive care unit admission and/or emergency surgical delivery

Primary outcomes:
measure: Brain structural connectivity
timeFrame: 3, 6, 12, 18, and 24 months of life
measure: Brain functional connectivity
timeFrame: 3, 6, 12, 18, and 24 months of life
measure: Brain De novo myelination
timeFrame: 3, 6, 12, 18, and 24 months of life
measure: Infant Cognitive Development
timeFrame: 6, 12, and 24 months of life
measure: Infant Early Learning Assessment
timeFrame: 18 and 24 months of life
measure: Infant Social Emotional Development
timeFrame: 3, 6, 12, 18, and 24 months of life
Secondary outcomes:
measure: Infant dietary assessment
timeFrame: 6, 9, 12, 18, and 24 months of life
measure: Breast milk nutrients profile
timeFrame: week 3, week 6, and 3 months of life
measure: Brain structure
timeFrame: 3, 6, 12, 18, and 24 months of life
measure: Blood nutrients profile (optional)
timeFrame: 6, 12, and 24 months of life
measure: Sleep
timeFrame: 3, 6, 12, 18, and 24 months of life
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Sean Deoni, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Viren D'Sa, MD
role: STUDY_DIRECTOR
References:
citation: Schneider N, Bruchhage MMK, O'Neill BV, Hartweg M, Tanguy J, Steiner P, Mutungi G, O'Regan J, Mcsweeney S, D'Sa V, Deoni SCL. A Nutrient Formulation Affects Developmental Myelination in Term Infants: A Randomized Clinical Trial. Front Nutr. 2022 Feb 10;9:823893. doi: 10.3389/fnut.2022.823893. eCollection 2022.