Urbana, Illinois 61801


Purpose:

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 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. 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.


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.


NCT ID:

NCT02457078


Primary Contact:

Principal Investigator
Gabriele Gratton, Ph.D., M.D.
University of Illinois at Chicago

Andrew Dinsmoor, B.S.
Phone: 217-244-1619
Email: dinsmoor@illinois.edu


Backup Contact:

Email: lowka@illinois.edu
Kathy Low, Ph.D.
Phone: 217-300-6719


Location Contact:

Urbana, Illinois 61801
United States

Andrew Dinsmoor, BS
Phone: 217-244-1619
Email: cnl-subjects@illinois.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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