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

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Postnatal Dietary Supplement; Dietary supplement: Control Supplement

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • Beckman Institute
      • Contact: Andrew Dinsmoor, BS; Phone Number: 217-244-1619; Email: cnl-subjects@illinois.edu
      • Contact: Kathy Low, PhD; Phone Number: 217-300-6719; Email: lowka@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: 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.	Dietary supplement: Control Supplement; Placebo Supplement:soybean oil and α-tocopherol (vitamin E)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant	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 activity will be assessed at 4 months of age
Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant	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.	Brain activity will be assessed at 9 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Dry Blood Spot at 4 months	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.	4 months of age
Infant Dry Blood Spot at 9 months	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.	9 months of age

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Gabriele Gratton, Ph.D., M.D., University of Illinois at Chicago

Publications and helpful links

General Publications

• Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.
• Gratton G, Fabiani M. Fast optical imaging of human brain function. Front Hum Neurosci. 2010 Jun 23;4:52. doi: 10.3389/fnhum.2010.00052. eCollection 2010.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: lutein; DHA; vitamin E; nutritional supplements; infant brain development
• Other Study ID Numbers: ANGC1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED