The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes
Condition: Traumatic Brain Injury (TBI); Chronic Traumatic Encephalopathy (CTE)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Diseases; Chronic Traumatic Encephalopathy
Study type: Interventional

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.
    

Intervention name(s): Fish Oil (DPA+EPA 2:1 ratio) Capsules; High Oleic Safflower Oil Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 3 times a week during the regular football season.; The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the "study masking", participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 3 times a week during the regular football season.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to treatment (3 grams DHA and EPA (2:1 weight ratio)) or placebo (3 grams high-oleic safflower oil) in a 1:1 allocation ratio based on their position on the football team and roster depth (starter vs. non-starter). Participants will be recruited as a single cohort. After screening, participants will be treated with DHA and EPA or matching placebo for 25 weeks (a full course of an American football season, including summer camp training sessions). A follow-up visit is scheduled 7 weeks after the final dosing at week 32 for recovery and adverse event evaluation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: CTE (Chronic Traumatic Encephalopathy); mTBI (Mild Traumatic Brain Injury); Concussion; MRI; Nf-L (Neurofilament Light Chain); Biomarker; Football