Clinical trial NCT04570995: Effect of Fish Oil on Athlete's Executive Function
Official title: Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) on Brain Executive Function in Student Athletes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Health
Brain Function
Brain Development
Keywords: Polyunsaturated fatty Acids
Executive Function abilities
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled, two-arm intervention study
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Barkley Deficits in Executive Functioning Scale (BDEFS)
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Stroop Test
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Stroop Test
timeFrame: Baseline, Day 1
measure: Trail Making Test
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Trail Making Test
timeFrame: Baseline, Day 1
measure: Stop-Signal Test
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Stop-Signal Test
timeFrame: Baseline, Day 1
measure: Digit Span
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Digit Span
timeFrame: Baseline, Day 1
measure: Wisconsin Card Sort Test
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Wisconsin Card Sort Test
timeFrame: Baseline, Day 1
measure: Circulating levels of fatty acids - EPA (eicosapentaenoic acid) in plasma
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Circulating levels of fatty acids - EPA on red blood cells
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Circulating levels of fatty acids - DHA (docosahexaenoic acid) on Red blood cells
timeFrame: visit #2 (~6-8 weeks after baseline)
measure: Circulating levels of fatty acids - DHA in plasma
timeFrame: visit #2 (~6-8 weeks after baseline)
Secondary outcomes:
measure: Capsule consumption compliance
timeFrame: Visits 2 (Week~6-8 weeks after baseline ) and visit 5 (up to 9 months)
measure: Weight
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: BMI
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Waist circumference
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Hip circumferences
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Depression, Anxiety and Stress Scale (DASS)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Inflammatory and/or injury biomarkers (e.g., isoprostanes)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of inflammatory and/or injury biomarkers (creatinine kinase)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of inflammatory and/or injury biomarkers (ROS) (Reactive oxygen species)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of Inflammatory and/or injury biomarkers (IGF) (Insulin-like growth factor 1)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of inflammatory and/or injury biomarkers (TNF) (Tumor necrosis factor)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of inflammatory and/or injury biomarkers (CRP) (C-reactive protein)
timeFrame: Visits 1 to 5, from baseline up to 9 months
measure: Levels of inflammatory biomarkers (IL-6, IL-8, IL-10) (Interleukin)
timeFrame: Post study - 9 months
measure: Sleep patterns
timeFrame: 4 Visits during 9 months (approximately 6-8 week intervals)
measure: Reaction time assessment
timeFrame: weekly intervals for 9 months of study
measure: Heart rate variability
timeFrame: From baseline up to 9 months
measure: Heart rate
timeFrame: From baseline up to 9 months
measure: Respiratory rate
timeFrame: From baseline up to 9 months
measure: Barkley Deficits in Executive Functioning Scale (BDEFS)
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
measure: Stroop Test
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
measure: Trail Making Test
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
measure: Stop-Signal Test
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
measure: Digit Span
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
measure: Wisconsin Card Sort Test
timeFrame: From Visit 3 (week ~12-16 weeks after baseline) to visit 5 (up to 9 months)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Elaheh Rahbar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.