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Completed

NCT Number: NCT05457023

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

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.

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Key information

Conditions

Brain Trauma Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Charcot-Marie-Tooth disease, Type 1F Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Rockhurst University, Kansas City, Missouri, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plasma Neurofilament Light (NF-L)

Other

Plasma NF-L is a biomarker of axonal brain injury following sports-related head impacts.

Omega-3 Index

Other

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

Other

HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading exposure during competitive play and is administered bi-weekly.

Primary outcomes

  1. Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season.

    Time frame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months

    Plasma neurofilament light (pg/mL) is a biomarker of axonal brain injury following sports-related head impacts.

  2. Change in purposeful soccer heading frequencies from baseline, during, and after a competitive season.

    Time frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks

    HeadCount is a web-based, structured, self-administered questionnaire to assess longer-term heading frequencies (#) during competitive play and is administered bi-weekly.

  3. Change in Omega-3 status from baseline, during, and after a competitive season.

    Time frame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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