Clinical trial NCT04796207: The Effects of Fish Oil Supplementation on the Brain Health of Collegiate Football Athletes
Official title: Study of Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) Supplementation on Biomarkers of Sub-Concussion Injuries in American Football
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury (TBI)
Chronic Traumatic Encephalopathy (CTE)
Keywords: CTE (Chronic Traumatic Encephalopathy)
mTBI (Mild Traumatic Brain Injury)
Concussion
MRI
Nf-L (Neurofilament Light Chain)
Biomarker
Football
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1) 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:

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

Primary outcomes:
measure: Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L
timeFrame: Baseline, Week 17, Week 26
measure: Changes in Sub-concussion Injury Related Inflammation Biomarkers - TNF-α
timeFrame: Baseline ans Week 26
measure: Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6
timeFrame: Baseline; Week 17; Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Floyd Chilton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Roberta Brinton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raikes AC, Hernandez GD, Mullins VA, Wang Y, Lopez C, Killgore WDS, Chilton FH, Brinton RD. Effects of docosahexaenoic acid and eicosapentaoic acid supplementation on white matter integrity after repetitive sub-concussive head impacts during American football: Exploratory neuroimaging findings from a pilot RCT. Front Neurol. 2022 Sep 15;13:891531. doi: 10.3389/fneur.2022.891531. eCollection 2022.