Healthy NutritionNCT01789866
DHA & Lutein and fMRI Brain Mapping in Healthy Children
An observational study of Healthy Nutrition, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 69 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 69 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: school-age children differentiated by intake of DHA and lutein
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Resaerch Center
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function 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:
- 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.
- 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.
Read the 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.
- Conditions
- Healthy Nutrition
- Keywords
- DHA, lutein, neurodevelopment, fMRI
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI data
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
Measured: 5 years 8 months to 6 years
Secondary outcomes (1)
cognitive development with standardized developmental tests
Assessment with the Kaufman Developmental Assessment Battery
Measured: 5 years 8 months to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Lamers, University of British Columbia
- Investigators
- Sheila M Innis, PhD, Principal investigator, Child & Family Research Institute, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789866
- Sponsor's protocol ID
- H12-01306
- Status last verified
- Aug 2023
- First submitted
- 20 Dec 2012
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function in Healthy Children
- ClinicalTrials.gov ID
- NCT01789866
- Acronym / sponsor ID
- H12-01306
- Conditions
- Healthy Nutrition
- Keywords
- DHA, lutein, neurodevelopment, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 69 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- school-age children differentiated by intake of DHA and lutein
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
cognitive development with standardized developmental tests
Time frame: 5 years 8 months to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila M Innis, PhD principal investigator
Child & Family Research Institute, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Nutrition, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI data (time frame: 5 years 8 months to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.