Infant Nutrition and Brain Development

The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Infant Development
• Intervention / Treatment: Other: Infant Formula: enriched level of myelin-relevant nutrients; Other: Infant formula: standard level of myelin-relevant nutrients

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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Reference Arm: Breastfed; Epidemiological reference group of breastfed infants.
Experimental: Investigational; Infant Formula: enriched level of myelin-relevant nutrients	Other: Infant Formula: enriched level of myelin-relevant nutrients; 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.; Other Names: Infant Formula
Active Comparator: Control; Infant formula: standard level of myelin-relevant nutrients	Other: Infant formula: standard level of myelin-relevant nutrients; 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.; Other Names: Infant Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	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].	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].	3, 6, 12, 18, and 24 months of life
Infant Cognitive Development	Standardized neurodevelopment test.	6, 12, and 24 months of life
Infant Early Learning Assessment	Computer-based cognitive tasks.	18 and 24 months of life
Infant Social Emotional Development	Parent report questionnaire.	3, 6, 12, 18, and 24 months of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant dietary assessment	Three days food records are planned at the specified time-frames.	6, 9, 12, 18, and 24 months of life
Breast milk nutrients profile	Nutrients (vitamins, minerals, and other nutrients) levels analyses in breast milk nutrients (subsample) [Physiological parameter].	week 3, week 6, and 3 months of life
Brain structure	MRI	3, 6, 12, 18, and 24 months of life
Blood nutrients profile (optional)	Nutrients (vitamins, minerals, and other nutrients) levels	6, 12, and 24 months of life
Sleep	Questionnaire	3, 6, 12, 18, and 24 months of life

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Sean Deoni, PhD, Rhode Island Hospital; Study Director: Viren D'Sa, MD, Rhode Island Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition, Brain Development, Cognition, Heathy Infants
• Other Study ID Numbers: 16.14.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: MRI scans will be shared between sites. No Personal Identifiable Information will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No