Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory in Infants

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Postnatal Dietary Supplement; Dietary Supplement: Control Supplement

• Registration Number: NCT02457078
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E.

Detailed Description

This project will investigate whether adding nutritional supplements to the diet will have beneficial effects on the development of infant brain networks (assessed at 4 and 9 months of age). The nutritional supplement will contain lutein (typically found in leafy vegetables),docosahexaenoic acid (DHA; a fatty acid typically found in cold-water fish such as salmon or tuna), and of vitamin E. This supplement will be taken orally, once a day for 9-10 months starting immediately after delivery. The investigators will also collect a dry blood spot (DBS) from the heel of the infant at 4 and 9 months of age to assess the amount of these nutrients reaching the infants' blood. At these same ages, the investigators will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Inclusion criteria for mothers at time of recruitment:

  1. Intention to breast feed for at least the first 3 months
  2. 18 years of age or older
  3. Willingness to abstain from multi-vitamins or other supplements that contain lutein and vitamin E during the study and take no more than 200 mg of DHA.
  4. Normal or corrected-to-normal vision
  5. Normal or corrected-to-normal hearing
  6. English is the dominant language spoken in the home.

Exclusion Criteria

• and/or early termination:

  1. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport.
  2. High risk pregnant mothers
  3. Macular Pigment Optical Density (MPOD) score greater than 0.6.
  4. Preterm birth (less than 37 weeks)
  5. Low birth weight (less than 2500 grams, < 5.5 pounds)
  6. Unable or unwilling to continue breast feeding within the first 3 months after birth.
  7. Unable or unwilling to continue taking the study supplement within the first 3 months after birth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postnatal Dietary Supplement	Postnatal Dietary Supplement	Dietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months.
Control Supplement	Control Supplement	Control Supplement: Capsule containing soybean oil and α-tocopheryl (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months.

Primary Outcome Measures

Name	Time	Method
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant	Brain activity will be assessed at 4 months of age	The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 4 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.
Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant	Brain activity will be assessed at 9 months of age	The current project will investigate whether nutritional supplements will have beneficial effects on infant brain networks at 9 months of age. We will use the Event-Related Optical Signal (EROS) to non-invasively record brain activity in the infants as they passively listen to sounds (e.g., novel sounds, speech sounds, words, etc.) and watch short video clips of moving objects (e.g., toys, children playing, etc) to look at whether the nutritional supplement influences brain development.

Secondary Outcome Measures

Name	Time	Method
Infant Dry Blood Spot at 4 months	4 months of age	We will also collect a dry blood spot (DBS) from the heel of the infant at 4 months of age to assess the amount of the nutrients reaching the infants' blood.
Infant Dry Blood Spot at 9 months	9 months of age	We will also collect a dry blood spot (DBS) from the heel of the infant at 9 months of age to assess the amount of the nutrients reaching the infants' blood.

Trial Locations

Locations (1)

Beckman Institute; 🇺🇸 Urbana, Illinois, United States