LCPUFA Supplementation: A Multi-Modality Imaging Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02076048

Enrollment

Registered

2014-03-03

Start date

2013-07-31

Completion date

2015-09-30

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

LCPUFA supplementation, Brain Imaging, MRI, MEG

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Event-Related Field (ERF) Amplitude and Latency	Within 1 year post enrollment	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.
Regional gray and white matter brain volume	Within 1 year post enrollment	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.

Secondary

Measure	Time frame	Description
Identify structural and metabolic mediators	Within 1 year post enrollment	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.

Countries

United States

Outcome results