Trials / Unknown
UnknownNCT02457078
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Illinois at Urbana-Champaign · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIETARY_SUPPLEMENT | Control Supplement | Placebo Supplement:soybean oil and α-tocopherol (vitamin E) |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2015-05-29
- Last updated
- 2017-05-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02457078. Inclusion in this directory is not an endorsement.