NCT03111927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

4 years

First QC Date

February 28, 2017

Last Update Submit

July 18, 2022

Conditions

HealthyInfant Development

Keywords

Nutrition, Brain Development, Cognition, Heathy Infants

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • Infant dietary assessment

    6, 9, 12, 18, and 24 months of life

  • Breast milk nutrients profile

    week 3, week 6, and 3 months of life

  • Brain structure

    3, 6, 12, 18, and 24 months of life

  • Blood nutrients profile (optional)

    6, 12, and 24 months of life

  • Sleep

    3, 6, 12, 18, and 24 months of life

Study Arms (3)

Reference Arm: Breastfed

NO INTERVENTION

Epidemiological reference group of breastfed infants.

Investigational

EXPERIMENTAL

Infant Formula: enriched level of myelin-relevant nutrients

Other: Infant Formula: enriched level of myelin-relevant nutrients

Control

ACTIVE COMPARATOR

Infant formula: standard level of myelin-relevant nutrients

Other: Infant formula: standard level of myelin-relevant nutrients

Interventions

Infant Formula: enriched level of myelin-relevant nutrientsOTHER

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.

Also known as: Infant Formula
Investigational
Infant formula: standard level of myelin-relevant nutrientsOTHER

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.

Also known as: Infant Formula
Control

Eligibility Criteria

Age2 Weeks - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • 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.

    PMID: 35242798DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Sean Deoni, PhD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

  • Viren D'Sa, MD

    Rhode Island Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind - Infant Formula arms are blinded; * Reference Arm - unblinded epidemiological reference arm * Allocation: Randomized for formula arms, efficacy study
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

April 13, 2017

Study Start

March 13, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

MRI scans will be shared between sites. No Personal Identifiable Information will be shared.

Locations

US(2)