Effect of Fish Oil on Athlete's Executive Function

Not Applicable

Terminated

• Conditions: Brain Health; Brain Function; Brain Development
• Interventions: Dietary Supplement: Fish Oil; Dietary Supplement: Safflower Oil

• Registration Number: NCT04570995
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2020-11-05
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 22

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

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Exclusion Criteria

• Unwillingness to consume a daily dietary supplement over the course of the study
• Allergy to dietary supplement components
• Lipid-lowering medication use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fish oil	Fish Oil	participants will be asked to consume a daily (5 days per week) dietary supplement containing fish oil encapsulated in soft gel capsules.
safflower oil	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.

Primary Outcome Measures

Name	Time	Method
Stop-Signal Test	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
Circulating levels of fatty acids - DHA in plasma	visit #2 (~6-8 weeks after baseline)	centrifuged to isolate plasma for DHA fatty acid analysis
Wisconsin Card Sort Test	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	visit #2 (~6-8 weeks after baseline)	centrifuged to isolate plasma for EPA fatty acid analysis
Barkley Deficits in Executive Functioning Scale (BDEFS)	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.
Circulating levels of fatty acids - EPA on red blood cells	visit #2 (~6-8 weeks after baseline)	centrifuged to isolate red blood cells for EPA fatty acid analysis
Stroop Test	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".
Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells	visit #2 (~6-8 weeks after baseline)	centrifuged to isolate red blood cells for DHA fatty acid analysis
Trail Making Test	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.
Digit Span	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.

Secondary Outcome Measures

Name	Time	Method
BMI	Visits 1 to 5, from baseline up to 9 months
Inflammatory and/or injury biomarkers (e.g., isoprostanes)	Visits 1 to 5, from baseline up to 9 months	quantify plasma levels of inflammatory biomarker assays
Capsule consumption compliance	Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)	Percentage capsules taken
Weight	Visits 1 to 5, from baseline up to 9 months
Waist circumference	Visits 1 to 5, from baseline up to 9 months
Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor)	Visits 1 to 5, from baseline up to 9 months	quantify plasma levels of inflammatory biomarker assays
Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein)	Visits 1 to 5, from baseline up to 9 months	quantify plasma levels of inflammatory biomarker assays
Depression, Anxiety and Stress Scale (DASS)	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.
Sleep patterns	4 Visits during 9 months (approximately 6-8 week intervals)	Time spent in each sleep stage: Light, REM, Slow Wave (Deep), and Awake.
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)	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.
Hip circumferences	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 (IGF) (Insulin-like growth factor 1)	Visits 1 to 5, from baseline up to 9 months	quantify plasma levels of inflammatory biomarker assays
Trail Making Test	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.
Levels of inflammatory and/or injury biomarkers (ROS) (Reactive oxygen species)	Visits 1 to 5, from baseline up to 9 months	quantify plasma levels of inflammatory biomarker assays
Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)	Post study - 9 months	quantify plasma levels of inflammatory biomarker assays
Stop-Signal Test	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
Stroop Test	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".
Wisconsin Card Sort Test	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.
Reaction time assessment	weekly intervals for 9 months of study	Baseball performance, assessed by reaction time assessment using the DynaVision system
Digit Span	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.

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States