The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes

Not Applicable

Completed

Conditions: Chronic Traumatic Encephalopathy (CTE)
Traumatic Brain Injury (TBI)

Interventions: Dietary Supplement: High Oleic Safflower Oil Capsules

Registration Number: NCT04796207

Lead Sponsor: University of Arizona

Brief Summary: Determine if the daily docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of American football season among collegiate football athletes.

Detailed Description: American football is one of the most popular sports in the U.S. Yet this sport is associated with increased risk of concussion (also known as mild traumatic brain injury, or mTBI) and sub-concussive injury from repeated head impacts (RHI) due to the aggressive and high-speed nature of the game. Current protective equipment used by players are not sufficient to reduce concussion incidence and severity, nor are there any therapeutics available to prevent concussion. This study is a randomized, double-blind, placebo controlled trial to determine if an omega-3 polyunsaturated fatty acid (PUFA) fish oil supplement containing 3.0 grams of docosahexaenoic acid (DHA; 22:6n-3) and eicosapentaenoic acid (EPA; 20:5n-3) can reduce blood biomarkers of sub-concussion injuries compared to placebo (high-oleic safflower oil) over a course of the American football season among collegiate football athletes.

The dosage of DHA/EPA used in this study is generally safe, and procedures involved, monthly blood draws, surveys, and Magnetic Resonance Imaging (MRI), pose minimal risks to participants. While this study provides no direct benefit to participants, successful outcomes of this study can benefit the society by shedding light on development of potential preventative therapeutics for sports-induced mTBI and brain injury from RHI. The risk-benefit profile is appropriate for conducting this study. Based on preclinical studies and previous clinical study results, the investigators expect that in comparison to placebo treatment, DHA and EPA treatment throughout the course of one American football season can maintain lower levels of sub-concussion associated biomarkers, inflammatory cytokines, and cardiovascular risk markers. The investigators also expect participants treated with DHA and EPA to have lower brain MRI imaging markers of sub concussion injury.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 38

Inclusion Criteria

University of Arizona National Collegiate Athletic Association (NCAA) Division I American football athletes cleared to participate in university athletics as determined by the team physician.

Exclusion Criteria

Chronic daily anti-inflammatory drugs (>20 d).
Medications for blood lipids.
Active fish oil or omega-3 fatty acid supplementation.
Consumption of more than two servings of fish per week.
Injured and unable to participate in regularly schedule conditioning or competitions.
Acute concussion experienced within 30 days of starting the study.
Fish allergies.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safflower Oil Capsules	High Oleic Safflower Oil Capsules	Participants in the treatment arm will receive 3 grams of high-oleic safflower oil) in a 1:1 allocation ratio for 25-weeks during regular football season.

Primary Outcome Measures

Name	Time	Method
Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L	Baseline, Week 17, Week 26	This primary outcome covers the change in the plasma brain biomarker Neurofilament Light Chains (Nf-L) due to sub-concussion injury from baseline to predetermined measurement time points. Nf-L (neuron specific intermediate proteins) are released upon injury to neurons and axons. Measured in picograms per milliliter (pg/ml)
Changes in Sub-concussion Injury Related Inflammation Biomarkers - TNF-α	Baseline ans Week 26	This primary outcome covers the change in the plasma inflammation biomarker Tumor Necrosis Factor-alpha (TNF-α), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. TNF-α is measured in picograms per milliliter (pg/ml).
Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6	Baseline; Week 17; Week 26	This primary outcome covers the change in the plasma inflammation biomarker Interleukin-6 (IL-6), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. IL-6 is measured in picograms per milliliter (pg/ml)