Brain HealthNCT04570995
Effect of Fish Oil on Athlete's Executive Function
A study testing Fish Oil and Safflower Oil in people with Brain Health and Brain Function, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The goal of this study is to determine the impact of long chain omega-3 PUFA (Polyunsaturated fatty acids) supplementation on executive function in collegiate athletes in a randomized, double-blind, placebo-controlled trial Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Health, Brain Function, Brain Development
- What is being tested?
- Fish Oil and Safflower Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 18 Dec 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Wake Forest University National Collegiate Athletic Association (NCAA) Division I baseball male student athletes cleared to participate in university athletics as determined by the team physician
- Age >/=18 years
Who cannot join
- Unwillingness to consume a daily dietary supplement over the course of the study
- Allergy to dietary supplement components
- Lipid-lowering medication use
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes
The goal of this study is to determine the impact of long chain omega-3 PUFA (Polyunsaturated fatty acids) supplementation on executive function in collegiate athletes in a randomized, double-blind, placebo-controlled trial
Read the detailed description
The main objective of this study is to determine the effect of daily oral intake of a fish oil capsule enriched in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on brain EF (Executive Function) and blood-based biomarkers among male collegiate baseball student athletes over the course of an academic school year
- Conditions
- Brain Health, Brain Function, Brain Development
- Being tested
- Fish Oil, Safflower Oil
- Keywords
- Polyunsaturated fatty Acids, Executive Function abilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week
Safflower OilDietary supplement
Also called high oleic acid (18:1, monounsaturated fatty acid)
Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week
| Study group | Role | What they receive |
|---|---|---|
| fish oil | Active comparator | participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules. Receives: Dietary Supplement: Fish Oil |
| safflower oil | Placebo comparator | participants will be asked to consume a daily (5 days per week) dietary supplement containing a placebo oil product (safflower oil) encapsulated in soft gel capsules. Receives: Dietary Supplement: Safflower Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barkley Deficits in Executive Functioning Scale (BDEFS)
Evaluate dimensions of adult executive functioning in daily life - self administered - Items are answered on a 4-point scale ranging from "1= Never or rarely" to " 4 = Very often"; α's range from 0.91 to 0.96. Higher scores are interpreted as indicating greater deficits in EF - The Barkley Deficits in Executive Functioning Scale is an 89 item self-report measure of executive functioning.
Measured: visit #2 (~6-8 weeks after baseline)
Stroop Test
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).
Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Measured: visit #2 (~6-8 weeks after baseline)
Stroop Test
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).
Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Measured: Baseline, Day 1
Trail Making Test
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Measured: visit #2 (~6-8 weeks after baseline)
Trail Making Test
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Measured: Baseline, Day 1
Stop-Signal Test
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed.
Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Measured: visit #2 (~6-8 weeks after baseline)
Stop-Signal Test
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed.
Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Measured: Baseline, Day 1
Digit Span
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Measured: visit #2 (~6-8 weeks after baseline)
Digit Span
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Measured: Baseline, Day 1
Wisconsin Card Sort Test
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility.
The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Measured: visit #2 (~6-8 weeks after baseline)
Wisconsin Card Sort Test
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility.
The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Measured: Baseline, Day 1
Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
centrifuged to isolate plasma for EPA fatty acid analysis
Measured: visit #2 (~6-8 weeks after baseline)
Circulating levels of fatty acids - EPA on red blood cells
centrifuged to isolate red blood cells for EPA fatty acid analysis
Measured: visit #2 (~6-8 weeks after baseline)
Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells
centrifuged to isolate red blood cells for DHA fatty acid analysis
Measured: visit #2 (~6-8 weeks after baseline)
Circulating levels of fatty acids - DHA in plasma
centrifuged to isolate plasma for DHA fatty acid analysis
Measured: visit #2 (~6-8 weeks after baseline)
Secondary outcomes (24)
Capsule consumption compliance
Percentage capsules taken
Measured: Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)
Weight
Measured: Visits 1 to 5, from baseline up to 9 months
BMI
Measured: Visits 1 to 5, from baseline up to 9 months
Waist circumference
Measured: Visits 1 to 5, from baseline up to 9 months
Hip circumferences
Measured: Visits 1 to 5, from baseline up to 9 months
Depression, Anxiety and Stress Scale (DASS)
Designed to measure the negative emotional states of depression, anxiety and stress - It consists of three 14-item subscales with each item scored on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Total scores are calculated by summing the items on each subscale, giving a score range of 0-42 on each subscale. Scores above 20, 14 and 25 on the depression, anxiety and stress subscales respectively are indicative of severe levels. Higher scores denotes worse outcomes.
Measured: Visits 1 to 5, from baseline up to 9 months
Inflammatory and/or injury biomarkers (e.g., isoprostanes)
quantify plasma levels of inflammatory biomarker assays
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (creatinine kinase)
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (ROS) (Reactive oxygen species)
quantify plasma levels of inflammatory biomarker assays
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of Inflammatory and/or injury biomarkers (IGF) (Insulin-like growth factor 1)
quantify plasma levels of inflammatory biomarker assays
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor)
quantify plasma levels of inflammatory biomarker assays
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein)
quantify plasma levels of inflammatory biomarker assays
Measured: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)
quantify plasma levels of inflammatory biomarker assays
Measured: Post study - 9 months
Sleep patterns
Time spent in each sleep stage: Light, REM, Slow Wave (Deep), and Awake.
Measured: 4 Visits during 9 months (approximately 6-8 week intervals)
Reaction time assessment
Baseball performance, assessed by reaction time assessment using the DynaVision system
Measured: weekly intervals for 9 months of study
Heart rate variability
Measured: From baseline up to 9 months
Heart rate
Measured: From baseline up to 9 months
Respiratory rate
Measured: From baseline up to 9 months
Barkley Deficits in Executive Functioning Scale (BDEFS)
Evaluate dimensions of adult executive functioning in daily life - self administered - Items are answered on a 4-point scale ranging from "1= Never or rarely" to " 4 = Very often"; α's range from 0.91 to 0.96. Higher scores are interpreted as indicating greater deficits in EF - The Barkley Deficits in Executive Functioning Scale is an 89 item self-report measure of executive functioning.
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Stroop Test
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning).
Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Trail Making Test
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Stop-Signal Test
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed.
Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Digit Span
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Wisconsin Card Sort Test
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility.
The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Measured: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start5 Nov 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Why it stopped: Sponsor unable to send smaller necessary capsules
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 Brain HealthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, two-arm intervention study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaheh Rahbar, PhD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570995
- Sponsor's protocol ID
- IRB00068607
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Innis SM. Dietary omega 3 fatty acids and the developing brain. Brain Res. 2008 Oct 27;1237:35-43. doi: 10.1016/j.brainres.2008.08.078. Epub 2008 Sep 9.
PubMed 18789910McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3.
PubMed 20130094Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24.
PubMed 29063592
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes
- ClinicalTrials.gov ID
- NCT04570995
- Acronym / sponsor ID
- IRB00068607
- Conditions
- Brain Health, Brain Function, Brain Development
- Keywords
- Polyunsaturated fatty Acids, Executive Function abilities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor unable to send smaller necessary capsules
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 30 Sep 2020 (actual)
- 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.
The goal of this study is to determine the impact of long chain omega-3 PUFA (Polyunsaturated fatty acids) supplementation on executive function in collegiate athletes in a randomized, double-blind, placebo-controlled trial
Detailed description
The main objective of this study is to determine the effect of daily oral intake of a fish oil capsule enriched in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on brain EF (Executive Function) and blood-based biomarkers among male collegiate baseball student athletes over the course of an academic school year
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, two-arm intervention study
| Arm | Type | Receives |
|---|---|---|
| fish oil | Active comparator | Dietary Supplement: Fish Oilparticipants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules. |
| safflower oil | Placebo comparator | Dietary Supplement: Safflower Oilparticipants will be asked to consume a daily (5 days per week) dietary supplement containing a placebo oil product (safflower oil) encapsulated in soft gel capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Wake Forest University National Collegiate Athletic Association (NCAA) Division I baseball male student athletes cleared to participate in university athletics as determined by the team physician
- Age >/=18 years
Key exclusion criteria (3 listed)
- Unwillingness to consume a daily dietary supplement over the course of the study
- Allergy to dietary supplement components
- Lipid-lowering medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish OilAlso: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week | Dietary supplement | fish oil |
| Safflower OilAlso: high oleic acid (18:1, monounsaturated fatty acid)Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week | Dietary supplement | safflower oil |
Primary outcome
Barkley Deficits in Executive Functioning Scale (BDEFS)
Time frame: visit #2 (~6-8 weeks after baseline)
Evaluate dimensions of adult executive functioning in daily life - self administered - Items are answered on a 4-point scale ranging from "1= Never or rarely" to " 4 = Very often"; α's range from 0.91 to 0.96. Higher scores are interpreted as indicating greater deficits in EF - The Barkley Deficits in Executive Functioning Scale is an 89 item self-report measure of executive functioning.
Stroop Test
Time frame: visit #2 (~6-8 weeks after baseline)
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Stroop Test
Time frame: Baseline, Day 1
Subjects will be asked to read words of colors, state the colors of various letters to test processing speed, and state the color of the font of a word when the actual word describes a conflicting color to test response inhibition (executive functioning). Three scores, as well as an interference score, are generated using the number of items completed on each page, with higher scores reflecting better performance and less interference on reading ability. T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal".
Trail Making Test
Time frame: visit #2 (~6-8 weeks after baseline)
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Trail Making Test
Time frame: Baseline, Day 1
Visual attention, task switching - self administered - The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test results are reported as the time that took to complete. Longer times denotes worse outcomes.
Stop-Signal Test
Time frame: visit #2 (~6-8 weeks after baseline)
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed. Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Stop-Signal Test
Time frame: Baseline, Day 1
Response inhibition - self administered - stop signal task is a test of inhibition of prepotent responses. It requires the participant to respond as quickly as possible to a predetermined stimulus, the go trial, but to abort any response when a subsequently presented stop signal is displayed. Speed and accuracy on the go trials are measured. The stop signal reaction time is calculated and reported
Digit Span
Time frame: visit #2 (~6-8 weeks after baseline)
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Digit Span
Time frame: Baseline, Day 1
Working memory - self administered -Digit Span measures verbal short-term memory, defined as the system that allows for temporary storage of information, and is crucial in everyday tasks such as remembering a telephone number or understanding long sentences - The average digit span for normal adults without error is seven plus or minus two. The Digit Span test is a measure of verbal short-term/working memory. Scores range from 0 to 28, with higher scores indicating better verbal short-term/working memory.
Wisconsin Card Sort Test
Time frame: visit #2 (~6-8 weeks after baseline)
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility. The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Wisconsin Card Sort Test
Time frame: Baseline, Day 1
Will be administered to assess preservation and abstract thinking. The The task measures how well people can adapt to the changing rules, and their cognitive flexibility. The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility. Higher scores show an impairment of cognitive flexibility.
Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
Time frame: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate plasma for EPA fatty acid analysis
Circulating levels of fatty acids - EPA on red blood cells
Time frame: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate red blood cells for EPA fatty acid analysis
Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells
Time frame: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate red blood cells for DHA fatty acid analysis
Circulating levels of fatty acids - DHA in plasma
Time frame: visit #2 (~6-8 weeks after baseline)
centrifuged to isolate plasma for DHA fatty acid analysis
24 secondary outcomes
Capsule consumption compliance
Time frame: Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)
Weight
Time frame: Visits 1 to 5, from baseline up to 9 months
BMI
Time frame: Visits 1 to 5, from baseline up to 9 months
Waist circumference
Time frame: Visits 1 to 5, from baseline up to 9 months
Hip circumferences
Time frame: Visits 1 to 5, from baseline up to 9 months
Depression, Anxiety and Stress Scale (DASS)
Time frame: Visits 1 to 5, from baseline up to 9 months
Inflammatory and/or injury biomarkers (e.g., isoprostanes)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (creatinine kinase)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (ROS) (Reactive oxygen species)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of Inflammatory and/or injury biomarkers (IGF) (Insulin-like growth factor 1)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein)
Time frame: Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)
Time frame: Post study - 9 months
Sleep patterns
Time frame: 4 Visits during 9 months (approximately 6-8 week intervals)
Reaction time assessment
Time frame: weekly intervals for 9 months of study
Heart rate variability
Time frame: From baseline up to 9 months
Heart rate
Time frame: From baseline up to 9 months
Respiratory rate
Time frame: From baseline up to 9 months
Barkley Deficits in Executive Functioning Scale (BDEFS)
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Stroop Test
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Trail Making Test
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Stop-Signal Test
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Digit Span
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Wisconsin Card Sort Test
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Results and safety
The study was stopped early (reason given: Sponsor unable to send smaller necessary capsules). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 18789910Innis SM. Dietary omega 3 fatty acids and the developing brain. Brain Res. 2008 Oct 27;1237:35-43. doi: 10.1016/j.brainres.2008.08.078. Epub 2008 Sep 9.
- Background: PubMed 20130094McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3.
- Background: PubMed 29063592Vesco AT, Young AS, Arnold LE, Fristad MA. Omega-3 supplementation associated with improved parent-rated executive function in youth with mood disorders: secondary analyses of the omega 3 and therapy (OATS) trials. J Child Psychol Psychiatry. 2018 Jun;59(6):628-636. doi: 10.1111/jcpp.12830. Epub 2017 Oct 24.
- Individual participant dataSharing planned: No
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Prediabetes, Brain Insulin Sensitivity
Not yet recruitingObservational study
A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period
Brain Health
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.
Elaheh Rahbar, PhD principal investigator
Wake Forest Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish Oil and Safflower Oil in people with Brain Health and Brain Function, run by Wake Forest University Health Sciences 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Mar 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 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Sponsor unable to send smaller necessary capsules). Results are not available in the source record.
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?
Barkley Deficits in Executive Functioning Scale (BDEFS) (time frame: visit #2 (~6-8 weeks after baseline)). The study lists 15 primary outcomes in all. 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 NCT04570995, 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 22 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.