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

NCT02457078 | Unknown

• 1 other identifier: ANGC1401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

nutritional supplements; lutein; DHA; vitamin E; infant brain development

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Infant Dry Blood Spot at 4 months

  4 months of age

• Infant Dry Blood Spot at 9 months

  9 months of age

Study Arms (2)

Postnatal Dietary Supplement

EXPERIMENTAL

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

Control Supplement

PLACEBO COMPARATOR

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

Interventions

Postnatal Dietary Supplement 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.

Postnatal Dietary Supplement

Control Supplement DIETARY_SUPPLEMENT

Placebo Supplement:soybean oil and α-tocopherol (vitamin E)

Control Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intention to breast feed for at least the first 3 months
• years of age or older
• 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.
• Normal or corrected-to-normal vision
• Normal or corrected-to-normal hearing
• English is the dominant language spoken in the home.

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Beckman Institute

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 24899160 BACKGROUND

• 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.

  PMID: 20631845 BACKGROUND

Study Officials

• Gabriele Gratton, Ph.D., M.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Dinsmoor, B.S.

CONTACT

217-244-1619; dinsmoor@illinois.edu

Kathy Low, Ph.D.

CONTACT

217-300-6719; lowka@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: May 29, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

US (1)