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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory and Language in Infants

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Postnatal Dietary Supplement
* Dietary Supplement: Control Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for mothers at time of recruitment: Intention to breast feed for at least the first 3 months 18 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postnatal Dietary Supplement<br>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<br>* 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.<br>|
| Placebo Comparator: Control Supplement<br>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<br>* Placebo Supplement:soybean oil and α-tocopherol (vitamin E)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Dry Blood Spot at 4 months | 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. | 4 months of age | 
| Infant Dry Blood Spot at 9 months | 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. | 9 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional supplements, lutein, vitamin E, infant brain development, DHA