Effect of Fish Oil on Athlete's Executive Function

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes

Conditions
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Brain Health, Brain Function, Brain Development

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Safflower Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled, two-arm intervention study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fish oil<br>participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules. | Dietary Supplement: Fish Oil<br>* Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week<br>* Other names: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA);|
| Placebo Comparator: safflower oil<br>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: Safflower Oil<br>* Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week<br>* Other names: high oleic acid (18:1, monounsaturated fatty acid);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | Baseline, Day 1 | 
| Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma | 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 | 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 | 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 | 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 | Percentage capsules taken | Visits 2 (Week 6-8 weeks after baseline ) and visit 5 (up to 9 months) | 
| Weight |  | Visits 1 to 5, from baseline up to 9 months | 
| BMI |  | Visits 1 to 5, from baseline up to 9 months | 
| Waist circumference |  | Visits 1 to 5, from baseline up to 9 months | 
| Hip circumferences |  | 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. | 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 | Visits 1 to 5, from baseline up to 9 months | 
| Levels of inflammatory and/or injury biomarkers (creatinine kinase) |  | 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 | 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 | 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 | 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 | 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 | Post study - 9 months | 
| Sleep patterns | 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 | Baseball performance, assessed by reaction time assessment using the DynaVision system | weekly intervals for 9 months of study | 
| Heart rate variability |  | From baseline up to 9 months | 
| Heart rate |  | From baseline up to 9 months | 
| Respiratory rate |  | 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. | 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. | 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. | 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 | 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. | 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. | From Visit 3 (week  12-16 weeks after baseline) to visit 5 (up to 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyunsaturated fatty Acids, Executive Function abilities