Infant Nutrition and Brain Development

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111927
• Other study ID #: 16.14.NRC
• Status: Completed
• Phase: N/A
• Start date: March 13, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: July 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Infant Development

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Infant Cognitive Development	Standardized neurodevelopment test.	6, 12, and 24 months of life
Primary	Infant Early Learning Assessment	Computer-based cognitive tasks.	18 and 24 months of life
Primary	Infant Social Emotional Development	Parent report questionnaire.	3, 6, 12, 18, and 24 months of life
Secondary	Infant dietary assessment	Three days food records are planned at the specified time-frames.	6, 9, 12, 18, and 24 months of life
Secondary	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
Secondary	Brain structure	MRI	3, 6, 12, 18, and 24 months of life
Secondary	Blood nutrients profile (optional)	Nutrients (vitamins, minerals, and other nutrients) levels	6, 12, and 24 months of life
Secondary	Sleep	Questionnaire	3, 6, 12, 18, and 24 months of life