Effect of Fish Oil on Athlete's Executive Function

NCT04570995 | Terminated DMC

• 1 other identifier: IRB00068607
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Health; Brain Function; Brain Development

Keywords

Polyunsaturated fatty Acids; Executive Function abilities

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (24)

• Capsule consumption compliance

  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

Study Arms (2)

fish oil

ACTIVE COMPARATOR

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

safflower oil

PLACEBO COMPARATOR

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

Interventions

Fish Oil DIETARY_SUPPLEMENT

Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week

Also known as: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)

fish oil

Safflower Oil DIETARY_SUPPLEMENT

Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week

Also known as: high oleic acid (18:1, monounsaturated fatty acid)

safflower oil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related 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.

  PMID: 18789910 BACKGROUND

• 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.

  PMID: 20130094 BACKGROUND

• 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.

  PMID: 29063592 BACKGROUND

MeSH Terms

Interventions

Fish Oils; Eicosapentaenoic Acid; Docosahexaenoic Acids; Safflower Oil; Fatty Acids, Monounsaturated

Intervention Hierarchy (Ancestors)

Oils; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Elaheh Rahbar, PhD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The capsules are of nearly identical color rendering them indistinguishable in appearance
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled, two-arm intervention study

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: November 5, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: March 22, 2023

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)