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Completed

NCT Number: NCT01789866

DHA & Lutein and fMRI Brain Mapping in Healthy Children

Studies suggest that lutein and n-3 fatty acids may influence the development of a child's brain and may be related to how well children learn. Both lutein and the n-3 fats (also known as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators are interested to understand the importance of n-3 fats and lutein to child brain development. Functional magnetic resonance imaging (fMRI) will make it possible to look into the brain from the outside and see which parts of the brain are being used as children complete working memory tasks. The investigators will study brain function using fMRI among children with different intakes of n-3 fats and lutein.

Hypothesis:

1. Children 6 years of age consuming < 25 mg/day DHA and < 400 μg lutein/day will show poorer activation of brain areas on fMRI than children consuming > 150 mg/day DHA and > 1,200 μg/day lutein. 2. Children consuming < 400 μg lutein/day and > 150 mg/day DHA will also show differences in fMRI results when compared to children consuming > 150 mg/day DHA and > 1,200 μg/day lutein.

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Key information

Conditions

Age range

69 month–78 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Child & Family Resaerch Center

Vancouver, British Columbia, V5Z 4H4, Canada

About this study

Study Design:

A cross-sectional observational study of 62 school-age children in Vancouver, Canada.

Dietary intake assessment:

Children's dietary intake over the previous four weeks was estimated by interview with a parent using a Food Frequency Questionnaire. Three 24h recalls were administered, using the five-pass review technique. The children's dietary intake of DHA was quantified using nutrient analysis software (ESHA Food Processor SQL, version 10.10.0.0; ESHA Research), using Canadian foods, and checking the fatty acid composition of all foods and beverages for accuracy, modifying if necessary based on labels or laboratory analysis of the product.

Blood Markers EDTA venous blood was collected and was centrifuged to collect Red Blood Cells (RBC). RBC fatty acids were extracted and quantified by routine gas liquid chromatography. RBC-DHA to DPA (n-6) ratio was used as an indicator of DHA status.

Cognitive Measures The Kaufman Assessment Battery for Children (KABC)-II (Kaufman, 2004) was administered by one of two individuals trained in child psychometric testing. The KABC consists of several scales: (1) the Sequential Processing Scale measures short-term memory; (2) the Learning Ability Scale measures long-term storage and retrieval; & (3) the Simultaneous Processing Scale measures visual processing. Results of these 3 scales may be combined to give a composite Mental Performance Index (MPI) score. The Delayed Recall subtest was used to evaluate long-term memory.

Statistical Analysis DHA intake and RBC-DHA:DPA were log transformed; transformed data were used in the subsequent analyses. Pearson's correlation tests were conducted to test (1) the associations between DHA intake and RBC-DHA:DPA ratio and (2) the associations between DHA intake and RBC-DHA:DPA with KABC-II domain scores.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • full-term
  • single birth (no multiple births)
  • no major illness or surgery requiring hospitalization likely to impact the outcomes
  • no metabolic, congenital or allergic disease that impact food intakes
  • parents have sufficient command of English language to complete the informed consent and study documents

The specific inclusion enrollment criteria for:

Group 1: children consuming <25 mg/day DHA and < 400 μg/day lutein, n=24; Group 2: children consuming >150 mg/day DHA and >1,200 μg/day lutein, n=24; Group 3: children consuming >150 mg/day DHA and <400 μg/day lutein, n=10;

Exclusion criteria

  • children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy
  • children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete
  • children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein
  • children of mothers who do not sign the informed consent
  • any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C&W MRI Patient Screening Form will be excluded from this study.

Treatment and study plan

Primary outcomes

  1. fMRI data

    Time frame: 5 years 8 months to 6 years

    fMRI data will be collected for subjects differentiated by DHA and lutein status completing tasks for working memory, working language, visual working memory and visual acuity

Secondary outcomes

  1. cognitive development with standardized developmental tests

    Time frame: 5 years 8 months to 6 years

    Assessment with the Kaufman Developmental Assessment Battery

Other outcomes

  1. plasma lutein and Red blood cell DHA

    Time frame: 5 years 8 months to 6 years

    plasma lutein and red blood cell DHA biochemistries

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function in Healthy Children

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2013
Registry last updated
Aug 18, 2023

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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