Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT01789866
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DHA & Lutein and fMRI Brain Mapping in Healthy Children
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function in Healthy Children
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: