Executive FunctionNCT02199808
Fatty Acids and Executive Function Development in 7-12 Year Olds
An observational study of Executive Function, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related changes in executive functions in children and older adults. Participants: Eighty-four typically-developing 7-to 12-year-old children. Procedure (methods): Participants and a caregiver will participate in 4 sessions. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2016
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in English. Every effort will be made to recruit roughly equal numbers of boys and girls. Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made to match the sample to the race and ethnicity of the region: 80% White, 15% African-American, and 5% Native American, Asian, and Other descent.
Who may be able to join
- Typically-developing children 7-12 years old
Who cannot join
- Children or parents who do not speak English
- Any diagnosis of a psychological illness
- History of seizures
- History of tobacco exposure during gestation
- History of alcohol exposure during gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-Chapel Hill's Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.
Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related changes in executive functions in children and older adults.
Participants: Eighty-four typically-developing 7-to 12-year-old children.
Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three sessions will consist of the screening. These sessions will be telephone calls to collect 24-hour diet information that will be used to determine whether they are eligible for the fourth session. Approximately 120 participants will be screened to find 84 participants who are eligible for the fourth session, in which participants will complete a series of tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that provides computerized versions of standardized cognitive tests. They will also complete a maze task in which they figure out a path through the maze by walking on the correct squares. Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.
- Conditions
- Executive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 7-9 year olds | These are children who are between 7 and 9 years old when they are tested. | |
| 10-12 year olds | These are children who are between 10 and 12 years old when they are tested. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error (count) and latency (in milliseconds) measures from executive function tasks
For one specific aim, the omega-6 to omega-3 fatty acid ratio will be determined by summing the omega-6 and omega-3 fatty acid levels in plasma and dividing omega-6 fatty acids by omega-3 fatty acids. The calculated ratio will be used to predict error and latency scores on executive function tasks.
For a second specific aim, the oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements will be used to predict the error and latency measures from executive function tasks.
Measured: One time with children who are 7-12 years old
Secondary outcomes (2)
Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)
Plasma levels of omega-6 and omega-3 fatty acids will be used to predict oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements in children who are 7-12 years old.
Measured: One time with children who are 7-12 years old.
Performance on the Maze as measured by Noldus Ethovision
Performance on the Maze as measured by Noldus Ethovision tracking system will be compared to performance on standardized measures of planning and spatial working memory.
Measured: One time with children who are 7-12 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Xi
- Responsible party
- Principal investigator, Carol Cheatham, PhD, University of North Carolina, Chapel Hill
- Investigators
- Carol L Cheatham, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199808
- Sponsor's protocol ID
- 14-0198
- Status last verified
- Dec 2020
- First submitted
- 23 Jul 2014
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingol TT, Li R, Boone KM, Rausch J, Klebanoff MA, Turner AN, Yeates KO, Nelin MA, Sheppard KW, Keim SA. Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity. J Nutr. 2019 Dec 1;149(12):2182-2190. doi: 10.1093/jn/nxz115.
PubMed 31187863Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
PubMed 29523147Sheppard KW, Cheatham CL. Executive functions and the omega-6-to-omega-3 fatty acid ratio: a cross-sectional study. Am J Clin Nutr. 2017 Jan;105(1):32-41. doi: 10.3945/ajcn.116.141390. Epub 2016 Nov 16.
PubMed 27852615
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acids and Executive Functions: Cortical Activation and Behavioral Performance.
- ClinicalTrials.gov ID
- NCT02199808
- Acronym / sponsor ID
- 14-0198
- Conditions
- Executive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Sigma Xi
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jul 2014 (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.
Purpose: To examine the effect of the omega-6 to omega-3 fatty acid ratio on age-related changes in executive functions in children and older adults.
Participants: Eighty-four typically-developing 7-to 12-year-old children.
Procedure (methods): Participants and a caregiver will participate in 4 sessions. Three sessions will consist of the screening. These sessions will be telephone calls to collect 24-hour diet information that will be used to determine whether they are eligible for the fourth session. Approximately 120 participants will be screened to find 84 participants who are eligible for the fourth session, in which participants will complete a series of tests on the Cambridge Neuropsychological Test Automated Battery (CANTAB) - a touch-screen device that provides computerized versions of standardized cognitive tests. They will also complete a maze task in which they figure out a path through the maze by walking on the correct squares. Brain activity will be recorded using a portable near-infrared spectroscopy (NIRS) system.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-9 year olds | – | –These are children who are between 7 and 9 years old when they are tested. |
| 10-12 year olds | – | –These are children who are between 10 and 12 years old when they are tested. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All participants will be typically-developing, healthy 7-to-12-year-olds who are fluent in English. Every effort will be made to recruit roughly equal numbers of boys and girls. Recruitment will be conducted irrespective of race and ethnicity. An attempt will be made to match the sample to the race and ethnicity of the region: 80% White, 15% African-American, and 5% Native American, Asian, and Other descent.
Key inclusion criteria (1 listed)
- Typically-developing children 7-12 years old
Key exclusion criteria (5 listed)
- Children or parents who do not speak English
- Any diagnosis of a psychological illness
- History of seizures
- History of tobacco exposure during gestation
- History of alcohol exposure during gestation
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
Error (count) and latency (in milliseconds) measures from executive function tasks
Time frame: One time with children who are 7-12 years old
For one specific aim, the omega-6 to omega-3 fatty acid ratio will be determined by summing the omega-6 and omega-3 fatty acid levels in plasma and dividing omega-6 fatty acids by omega-3 fatty acids. The calculated ratio will be used to predict error and latency scores on executive function tasks. For a second specific aim, the oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS) measurements will be used to predict the error and latency measures from executive function tasks.
2 secondary outcomes
Oxygenated and deoxygenated hemoglobin concentrations from near-infrared spectroscopy (NIRS)
Time frame: One time with children who are 7-12 years old.
Performance on the Maze as measured by Noldus Ethovision
Time frame: One time with children who are 7-12 years old
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 16 Dec 2020.
- Derived from this study: PubMed 31187863Ingol TT, Li R, Boone KM, Rausch J, Klebanoff MA, Turner AN, Yeates KO, Nelin MA, Sheppard KW, Keim SA. Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity. J Nutr. 2019 Dec 1;149(12):2182-2190. doi: 10.1093/jn/nxz115.
- Derived from this study: PubMed 29523147Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
- Derived from this study: PubMed 27852615Sheppard KW, Cheatham CL. Executive functions and the omega-6-to-omega-3 fatty acid ratio: a cross-sectional study. Am J Clin Nutr. 2017 Jan;105(1):32-41. doi: 10.3945/ajcn.116.141390. Epub 2016 Nov 16.
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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.
Carol L Cheatham, Ph.D. principal investigator
University of North Carolina, Chapel Hill
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 Executive Function, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 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 16 Dec 2020. 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 United States. 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?
Error (count) and latency (in milliseconds) measures from executive function tasks (time frame: One time with children who are 7-12 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02199808, which also lists 3 linked publications.
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 16 Dec 2020.