Plasma Neurofilament Light and Its Relationship With Omega-3 Status and Soccer Heading in Women Soccer Players
A Blood Biomarker for Sports-Related Brain Injury and Its Relationship With Omega-3 Status and Purposeful Soccer Heading in Free-Living Collegiate Women Soccer Players During and After a Competitive Season
1 other identifier
observational
27
1 country
2
Brief Summary
The purpose of this study is to (1) assess how a competitive season of purposeful gameplay soccer heading in collegiate women soccer players is related to a blood biomarker for sports-related brain injury, plasma neurofilament light (NF-L), and (2) examine how a player's omega-3 status is related to plasma NF-L concentration changes during and after a competitive season of gameplay soccer heading.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2023
CompletedNovember 13, 2023
November 1, 2023
1.3 years
July 7, 2022
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season.
Plasma neurofilament light (pg/mL) is a biomarker of axonal brain injury following sports-related head impacts.
Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Change in purposeful soccer heading frequencies from baseline, during, and after a competitive season.
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading frequencies (#) during competitive play and is administered bi-weekly.
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks
Change in Omega-3 status from baseline, during, and after a competitive season.
Omega-3 Index (%) is the omega-3 fatty acid content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) within membrane of red blood cell. It is expressed as EPA+DHA as a percent of total identified fatty acids.
Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Study Arms (1)
Collegiate Women Soccer Players
National Collegiate Athletic Association (NCAA) players.
Interventions
Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.
Omega-3 Index is the omega-3 fatty acid content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) within the erythrocyte cell membrane. It is expressed as EPA+DHA as a percent of total identified fatty acids.
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.
Eligibility Criteria
Collegiate women soccer players who actively compete at the NCAA Division 1-A competition level.
You may qualify if:
- At least 18 years of age.
- Active player on the university's current team roster for the upcoming competitive season.
- Is eligible to participate in games and is not redshirting.
You may not qualify if:
- Is recovering from a Physician diagnosed concussion.
- Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Missouri Kansas City
Kansas City, Missouri, 64108, United States
Rockhurst University
Kansas City, Missouri, 64110, United States
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron F Carbuhn, PhD
University of Kansas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 7, 2022
First Posted
July 13, 2022
Study Start
July 28, 2022
Primary Completion
November 9, 2023
Study Completion
November 9, 2023
Last Updated
November 13, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share