LCPUFA Supplementation: A Multi-Modality Imaging Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to take images of the brain in order to see if long-chain polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and function in middle childhood.

Detailed Description
-----------------
LCPUFAs are essential fatty acids that are found in all cells of the body, particularly in the brain, retina and other nervous tissue. LCPUFAs are found naturally in seeds, nuts, fish and human breast milk. The body can also make LCPUFAs from shorter-chain fatty acid precursors. The researchers in the study have previously found that LCPUFA supplementation during infancy has a beneficial effect on vision and development in the early years of life. However, researchers feel there is a growing need to better understand if there are structural and/or functional changes in the brain that explain these benefits. It is also important to understand if changes in development are still present later in childhood.

Official Title
-----------------
LCPUFA Supplementation: A Multi-Modality Imaging Study

Conditions
-----------------
Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents consent for children and children have the ability to assent Participation as an infant in the original study Exclusion Criteria: Those with orthodontic braces or extensive dental work that would make them unable to have an MRI

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previous LCPUFA Supplementation<br>Children between the ages of 7 and 10 that were previously enrolled in a study of supplemented LCPUFA formula. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-Related Field (ERF) Amplitude and Latency | We will use an MEG Event-Related Field (ERF) to study the development of children's cognitive capabilities. The waveform components associated with information processing and response inhibition will be measured in order to assess the developmental progress of LCPUFA effects with increasing age. | Within 1 year post enrollment | 
| Regional gray and white matter brain volume | Structural brain imaging is widely used to measure gray and white matter maturation patterns in young children. We will use automated, sensitive, and validated methods to test whether LCPUFA supplementation positively impacts changes in the brain associated with higher functioning and intelligence. | Within 1 year post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify structural and metabolic mediators | In a single imaging session, we will measure metabolic biomarkers associated with cellular mechanisms such as bioenergetics, membrane status, and oxidative state, each of which have been implicated as associated with LCPUFA supplementation. | Within 1 year post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LCPUFA supplementation, Brain Imaging, MRI, MEG