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Completed

NCT Number: NCT02076048

LCPUFA Supplementation: A Multi-Modality Imaging Study

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.

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Key information

Conditions

Child Development

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Event-Related Field (ERF) Amplitude and Latency

    Time frame: 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.

  2. Regional gray and white matter brain volume

    Time frame: 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 outcomes

  1. Identify structural and metabolic mediators

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kathleen Gustafson, Ph.D.

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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