Healthy
Conditions
Keywords
nutritional supplements, lutein, DHA, vitamin E, infant brain development
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.
Interventions
DIETARY_SUPPLEMENTPostnatal 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_SUPPLEMENTControl Supplement
Placebo Supplement:soybean oil and α-tocopherol (vitamin E)
Sponsors
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactAndrew Dinsmoor, B.S.
Backup ContactKathy Low, Ph.D.
Outcome results
None listed