NCT03582267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

June 27, 2018

Last Update Submit

September 12, 2019

Conditions

Head Trauma

Outcome Measures

Primary Outcomes (1)

  • Blood concentration of neurofilament light protein

    Concentrations of neuronally derived proteins measured in blood

    12 times throughout course of 1 year

Study Arms (2)

Dietary Supplement

EXPERIMENTAL

Docosahexaenoic Acid (DHA)

Dietary Supplement: Docosahexaenoic Acid (DHA)

No Intervention

NO INTERVENTION

No Docosahexaenoic Acid supplementation

Interventions

Docosahexaenoic Acid (DHA)DIETARY_SUPPLEMENT

Daily administration of docosahexaenoic Acid (DHA). 2 grams of DHA liquid concentrate administered per day throughout trial period.

Also known as: Brain Armor DHA Liquid Concentrate
Dietary Supplement

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Christian Universti

Fort Worth, Texas, 76129, United States

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 10, 2018

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations

US(1)