LCPUFA Supplementation: A Multi-Modality Imaging Study

Child Development Clinical Trial

Official title:

LCPUFA Supplementation: A Multi-Modality Imaging Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076048
• Other study ID #: LCPUFA Supplementation
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: October 6, 2015
• Start date: July 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Child Development

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Gustafson, Ph.D.	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No