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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04796207
Study type	Interventional
Source	University of Arizona
Contact
Status	Completed
Phase	N/A
Start date	May 28, 2019
Completion date	January 28, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02878577` - Monitoring the Alterations That Occur in the Brain Following Traumatic Brain Injury
Active, not recruiting	`NCT02918994` - LearningRx Cognitive Training for TBI	N/A
Completed	`NCT02524067` - Modified Environment for Agitation in Patients With TBI	N/A
Completed	`NCT01760785` - Valproate for Mood Swings and Alcohol Use Following Head Injury	N/A
Recruiting	`NCT05033444` - A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers	Phase 1
Completed	`NCT01750268` - Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI	Phase 4
Recruiting	`NCT01512524` - Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury	N/A
Completed	`NCT02657135` - Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury	N/A
Completed	`NCT01956136` - Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury	N/A
Not yet recruiting	`NCT04003285` - Allopregnanolone in Chronic Complex Traumatic Brain Injury	Phase 2
Withdrawn	`NCT02356861` - LED Light Therapy to Improve Cognitive & Psychosocial Function in TBI-PTSD Veterans	N/A
Recruiting	`NCT04930146` - Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients	N/A
Withdrawn	`NCT01891383` - Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Completed	`NCT02764983` - Occupational Therapy Driving Intervention for Returning Combat Veterans.	N/A
Withdrawn	`NCT01779427` - Attention Intervention Management	N/A
Completed	`NCT01118195` - Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans	N/A
Completed	`NCT01547780` - Translocator Protein and Inflammation After Traumatic Brain Injury	Phase 1/Phase 2
Recruiting	`NCT03874208` - Prediction for Coma Recovery With Comaweb	N/A
Completed	`NCT03314584` - Managing MTBI-related Headaches With rTMS	N/A
Completed	`NCT02172703` - Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms