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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
189
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
Feeding with the assigned infant formula begun as soon as the child was enrolled in the study (from 2 weeks up to 5 weeks of life) and lasted up to 12 months of age (+/- 2 weeks). The volume of feed required by the child per day depended upon age, weight, and appetite. The product was given daily ad libitum to the child from enrollment up to 12 months.
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Brain structural connectivity
Longitudinal analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\].
Time frame: 3, 6, 12, 18, and 24 months of life
Brain functional connectivity
Cross-sectional analysis de novo myelination and comparison between the 3 study arms De novo myelination being assessed by brain magnetic resonance imaging (MRI; multicomponent relaxometry). \[Physiological marker, MRI\].
Time frame: 3, 6, 12, 18, and 24 months of life
Brain De novo myelination
Brain magnetic resonance imaging (MRI) derived measures (volumetric anatomical imaging) \[Physiological marker, MRI\].
Time frame: 3, 6, 12, 18, and 24 months of life
Infant Cognitive Development
Standardized neurodevelopment test.
Time frame: 6, 12, and 24 months of life
Infant Early Learning Assessment
Computer-based cognitive tasks.
Time frame: 18 and 24 months of life
Infant Social Emotional Development
Parent report questionnaire.
Time frame: 3, 6, 12, 18, and 24 months of life
Infant dietary assessment
Three days food records are planned at the specified time-frames.
Time frame: 6, 9, 12, 18, and 24 months of life
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Breast milk nutrients profile
Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) \[Physiological parameter\].
Time frame: week 3, week 6, and 3 months of life
Brain structure
MRI
Time frame: 3, 6, 12, 18, and 24 months of life
Blood nutrients profile (optional)
Nutrients (vitamins, minerals, and other nutrients) levels
Time frame: 6, 12, and 24 months of life
Sleep
Questionnaire
Time frame: 3, 6, 12, 18, and 24 months of life