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

NCT04796207 | Completed Results DMC

• 1 other identifier: IRB1904553365
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Changes in Brain Biomarkers Due to Sub-concussion Injury - Nf-L

  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)

  Baseline, Week 17, Week 26

• Changes in Sub-concussion Injury Related Inflammation Biomarkers - TNF-α

  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).

  Baseline ans Week 26

• Changes in Sub-concussion Injury Related Inflammation Biomarkers - IL-6

  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)

  Baseline; Week 17; Week 26

Study Arms (2)

Fish Oil Capsules

EXPERIMENTAL

Participants in the treatment arm will receive 3 grams of DHA and EPA (2:1 weight ratio) 5 times a week for 25-weeks during regular football season.

Dietary Supplement: Fish Oil (DPA+EPA 2:1 ratio) Capsules

Safflower Oil Capsules

PLACEBO COMPARATOR

Participants in the treatment arm will receive 3 grams of high-oleic safflower oil (in a 1:1 allocation ratio) 5 times a week for 25-weeks during regular football season.

Dietary Supplement: High Oleic Safflower Oil Capsules

Interventions

Fish Oil (DPA+EPA 2:1 ratio) Capsules DIETARY_SUPPLEMENT

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 5 times a week during the regular football season.

Fish Oil Capsules

High Oleic Safflower Oil Capsules DIETARY_SUPPLEMENT

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 5 times a week during the regular football season.

Safflower Oil Capsules

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Age: 18-25 Gender: Male Ethnicity: All races and ethnicities
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (1)

• 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.

  PMID: 36188406 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Chronic Traumatic Encephalopathy; Brain Concussion; Charcot-Marie-Tooth disease, Type 1F

Interventions

Fish Oils; Capsules

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injury, Chronic; Neurodegenerative Diseases; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Floyd H. Chilton
• Organization: University of Arizona

fchilton@arizona.edu

520-621-5327

Study Officials

• Floyd Chilton, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Roberta Brinton, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel will be kept blind to treatment assignments. The treatment assignment for each participant will be available to the investigator in a sealed envelope that may be opened only in the case of a serious adverse event which the investigator feels cannot be adequately treated without knowing the identity of the study medication. Code breakers will be collected and reviewed at the end of the study. If the blinding has been broken, then the investigator will provide documentation regarding the fact and indicate the other staff that received this information.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Nutritional Sciences Director, Precision Nutrition & Wellness Initiative Associate Director,The BIO5 Institute

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 12, 2021
• Study Start: May 28, 2019
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Locations

US (1)