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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
22
Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week
Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week
Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
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.
Time frame: 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".
Time frame: 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".
Time frame: 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.
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Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 1
Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
centrifuged to isolate plasma for EPA fatty acid analysis
Time frame: 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
Time frame: 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
Time frame: visit #2 (~6-8 weeks after baseline)
Circulating levels of fatty acids - DHA in plasma
centrifuged to isolate plasma for DHA fatty acid analysis
Time frame: visit #2 (~6-8 weeks after baseline)
Capsule consumption compliance
Percentage capsules taken
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)
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.
Time frame: 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
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)
quantify plasma levels of inflammatory biomarker assays
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)
quantify plasma levels of inflammatory biomarker assays
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post study - 9 months
Sleep patterns
Time spent in each sleep stage: Light, REM, Slow Wave (Deep), and Awake.
Time frame: 4 Visits during 9 months (approximately 6-8 week intervals)
Reaction time assessment
Baseball performance, assessed by reaction time assessment using the DynaVision system
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)
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.
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)