- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04570995
Effect of Fish Oil on Athlete's Executive Function
Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unwillingness to consume a daily dietary supplement over the course of the study
- Allergy to dietary supplement components
- Lipid-lowering medication use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: fish oil
participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules.
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Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week
Other Names:
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Placebo Comparator: safflower oil
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.
|
Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
visit #2 (~6-8 weeks after baseline)
|
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". |
visit #2 (~6-8 weeks after baseline)
|
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". |
Baseline, Day 1
|
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. |
visit #2 (~6-8 weeks after baseline)
|
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. |
Baseline, Day 1
|
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 |
visit #2 (~6-8 weeks after baseline)
|
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 |
Baseline, Day 1
|
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.
|
visit #2 (~6-8 weeks after baseline)
|
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.
|
Baseline, Day 1
|
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. |
visit #2 (~6-8 weeks after baseline)
|
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. |
Baseline, Day 1
|
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
|
visit #2 (~6-8 weeks after baseline)
|
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
|
visit #2 (~6-8 weeks after baseline)
|
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
|
visit #2 (~6-8 weeks after baseline)
|
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
|
visit #2 (~6-8 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capsule consumption compliance
Time Frame: Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)
|
Percentage capsules taken
|
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
|
Visits 1 to 5, from baseline up to 9 months
|
|
BMI
Time Frame: Visits 1 to 5, from baseline up to 9 months
|
Visits 1 to 5, from baseline up to 9 months
|
|
Waist circumference
Time Frame: Visits 1 to 5, from baseline up to 9 months
|
Visits 1 to 5, from baseline up to 9 months
|
|
Hip circumferences
Time Frame: Visits 1 to 5, from baseline up to 9 months
|
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
|
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.
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
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
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
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
|
quantify plasma levels of inflammatory biomarker assays
|
Post study - 9 months
|
Sleep patterns
Time Frame: 4 Visits during 9 months (approximately 6-8 week intervals)
|
Time spent in each sleep stage: Light, REM, Slow Wave (Deep), and Awake.
|
4 Visits during 9 months (approximately 6-8 week intervals)
|
Reaction time assessment
Time Frame: weekly intervals for 9 months of study
|
Baseball performance, assessed by reaction time assessment using the DynaVision system
|
weekly intervals for 9 months of study
|
Heart rate variability
Time Frame: From baseline up to 9 months
|
From baseline up to 9 months
|
|
Heart rate
Time Frame: From baseline up to 9 months
|
From baseline up to 9 months
|
|
Respiratory rate
Time Frame: From baseline up to 9 months
|
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)
|
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.
|
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)
|
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". |
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)
|
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. |
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)
|
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 |
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)
|
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.
|
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)
|
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. |
From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
|
Collaborators and Investigators
Publications and helpful links
General 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.
- McNamara 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.
- Vesco 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00068607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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