The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players

September 12, 2019 updated by: Jonathan Oliver, Texas Christian University
Nutrition interventions may present a safe and relatively risk free intervention for protection against subconcussive impacts. Docosahexaenoic acid (DHA, 22:6n-3) is the principal Omega 3 polyunsaturated fatty acid in the brain, playing an integral role in the brain's development and structural integrity. The goal of this study is to determine if supplementation with DHA attenuates blood biomarkers of repetitive head trauma linked to sub-concussive impacts sustained in rugby participation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76129
        • Texas Christian Universti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Canadian national rugby athletes on 7s and 15s teams

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Supplement
Docosahexaenoic Acid (DHA)
Dietary supplement: Docosahexaenoic Acid (DHA)
Daily administration of docosahexaenoic Acid (DHA). 2 grams of DHA liquid concentrate administered per day throughout trial period.
Other Names:
  • Brain Armor DHA Liquid Concentrate
No Intervention: No Intervention
No Docosahexaenoic Acid supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood concentration of neurofilament light protein
Time Frame: 12 times throughout course of 1 year
Concentrations of neuronally derived proteins measured in blood
12 times throughout course of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Christian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1706-066-1706

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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