Clinical trial NCT02457078: Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory in Infants
Official title: Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory and Language in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: nutritional supplements
lutein
DHA
vitamin E
infant brain development
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brain Imaging (Event-Related Optical Signal) of breastfed 4 month old infant
timeFrame: Brain activity will be assessed at 4 months of age
measure: Brain Imaging (Event-Related Optical Signal) of breastfed 9 month old infant
timeFrame: Brain activity will be assessed at 9 months of age
Secondary outcomes:
measure: Infant Dry Blood Spot at 4 months
timeFrame: 4 months of age
measure: Infant Dry Blood Spot at 9 months
timeFrame: 9 months of age
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Beckman Institute
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Gabriele Gratton, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.