Back to resultsThe Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Primary Purpose
Head Trauma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docosahexaenoic Acid (DHA)
Sponsored by
About this trial
This is an interventional basic science trial for Head Trauma
Eligibility Criteria
Inclusion Criteria:
- Canadian national rugby athletes on 7s and 15s teams
Exclusion Criteria:
- None
Sites / Locations
- Texas Christian Universti
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Dietary Supplement
No Intervention
Arm Description
Docosahexaenoic Acid (DHA)
No Docosahexaenoic Acid supplementation
Outcomes
Primary Outcome Measures
Blood concentration of neurofilament light protein
Concentrations of neuronally derived proteins measured in blood
Secondary Outcome Measures
Full Information
NCT ID
NCT03582267
First Posted
June 27, 2018
Last Updated
September 12, 2019
Sponsor
Texas Christian University
1. Study Identification
Unique Protocol Identification Number
NCT03582267
Brief Title
The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Official Title
The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Supplement
Arm Type
Experimental
Arm Description
Docosahexaenoic Acid (DHA)
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No Docosahexaenoic Acid supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic Acid (DHA)
Other Intervention Name(s)
Brain Armor DHA Liquid Concentrate
Intervention Description
Daily administration of docosahexaenoic Acid (DHA). 2 grams of DHA liquid concentrate administered per day throughout trial period.
Primary Outcome Measure Information:
Title
Blood concentration of neurofilament light protein
Description
Concentrations of neuronally derived proteins measured in blood
Time Frame
12 times throughout course of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Canadian national rugby athletes on 7s and 15s teams
Exclusion Criteria:
None
Facility Information:
Facility Name
Texas Christian Universti
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Docosahexaenoic Acid Supplementation on Biomarkers of Concussion Over the Course of a Year in Canadian National Rugby Players
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