Plasma Neurofilament Light and Its Relationship With Omega-3 Status and Soccer Heading in Women Soccer Players

Brain Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05457023
• Other study ID #: STUDY00148618
• Status: Completed
• Start date: July 28, 2022
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Is recovering from a Physician diagnosed concussion.
• Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Brain Trauma

Intervention

Other:
• Plasma Neurofilament Light (NF-L)
Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.
• Omega-3 Index
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 Questionnaire
HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.

Locations

Country	Name	City	State
United States	Rockhurst University	Kansas City	Missouri
United States	University of Missouri Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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