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

NCT04796207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-05-09

Study results available
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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)

Interventions

DIETARY_SUPPLEMENT

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

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.

DIETARY_SUPPLEMENT

High Oleic Safflower Oil Capsules

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.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Floyd Chilton, Ph.D. · University of Arizona

  • Roberta Brinton, Ph.D. · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-28
Primary Completion
2020-01-28
Completion
2020-01-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796207 on ClinicalTrials.gov