Effect of Fish Oil on Athlete's Executive Function

Brain Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04570995
• Other study ID #: IRB00068607
• Status: Terminated
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: September 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Development
• Brain Function
• Brain Health

Intervention

Dietary Supplement:
• Fish Oil
Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week
• Safflower Oil
Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"; a'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)
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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	Capsule consumption compliance	Percentage capsules taken	Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)
Secondary	Weight		Visits 1 to 5, from baseline up to 9 months
Secondary	BMI		Visits 1 to 5, from baseline up to 9 months
Secondary	Waist circumference		Visits 1 to 5, from baseline up to 9 months
Secondary	Hip circumferences		Visits 1 to 5, from baseline up to 9 months
Secondary	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
Secondary	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
Secondary	Levels of inflammatory and/or injury biomarkers (creatinine kinase)		Visits 1 to 5, from baseline up to 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)	quantify plasma levels of inflammatory biomarker assays	Post study - 9 months
Secondary	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)
Secondary	Reaction time assessment	Baseball performance, assessed by reaction time assessment using the DynaVision system	weekly intervals for 9 months of study
Secondary	Heart rate variability		From baseline up to 9 months
Secondary	Heart rate		From baseline up to 9 months
Secondary	Respiratory rate		From baseline up to 9 months
Secondary	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"; a'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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)