Traumatic Brain Injury (TBI) Clinical Trial
Official title:
Study of Effect of Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) Supplementation on Biomarkers of Sub-Concussion Injuries in American Football
Verified date | March 2021 |
Source | University of Arizona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determine if the daily docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA) supplement will reduce serum levels of biomarkers of sub-concussion injuries over a course of American football season among collegiate football athletes.
Status | Completed |
Enrollment | 38 |
Est. completion date | January 28, 2020 |
Est. primary completion date | January 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: 1) University of Arizona National Collegiate Athletic Association (NCAA) Division I American football athletes cleared to participate in university athletics as determined by the team physician. Exclusion Criteria: 1. Chronic daily anti-inflammatory drugs (>20 d). 2. Medications for blood lipids. 3. Active fish oil or omega-3 fatty acid supplementation. 4. Consumption of more than two servings of fish per week. 5. Injured and unable to participate in regularly schedule conditioning or competitions. 6. Acute concussion experienced within 30 days of starting the study. 7. Fish allergies. |
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in brain biomarkers due to sub-concussion injury - Nf-L | This primary outcome covers the change in the plasma brain biomarker Neurofilament Light Chains (Nf-L) due to sub-concussion injury from baseline to predetermined measurement time points. Nf-L (neuron specific intermediate proteins) are released upon injury to neurons and axons. Measured in picograms per milliliter (pg/ml) | Baseline; then once a month until the end of the study, up to 8 months. | |
Primary | Changes in brain biomarkers due to sub-concussion injury - Tau | This primary outcome covers the change in the plasma brain biomarker Tau protein due to sub-concussion injury from baseline to predetermined measurement time points. Tau protein accumulates in the brain after injury. Tau protein is measured in picograms per milliliter (pg/ml) | Baseline; then once a month until the end of the study, up to 8 months. | |
Primary | Changes in brain biomarkers due to sub-concussion injury - UCH-L1 | This primary outcome covers the change in the plasma brain biomarker Ubiquitin C-Terminal Hydrolase L1 (UCH-L1) due to sub-concussion injury from baseline to predetermined measurement time points. UCH-L1 levels are elevated in the cerebrospinal fluid (CSF) and serum for several days after severe traumatic brain injury. UCH-L1 is measured in nanograms per milliliter (ng/ml) | Baseline; then once a month until the end of the study, up to 8 months. | |
Primary | Changes in sub-concussion injury related inflammation biomarkers - CRP | This primary outcome covers the change in the plasma inflammation biomarker C-reactive Protein (CRP), a marker of general inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. CRP is measured in milligrams per liter (mg/L)/ | Baseline; then once a month until the end of the study, up to 8 months. | |
Primary | Changes in sub-concussion injury related inflammation biomarkers - TNF-a | This primary outcome covers the change in the plasma inflammation biomarker Tumor Necrosis Factor-alpha (TNF-a), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. TNF-a is measured in picograms per milliliter (pg/ml). | Baseline; then once a month until the end of the study, up to 8 months. | |
Primary | Changes in sub-concussion injury related inflammation biomarkers - IL-6 | This primary outcome covers the change in the plasma inflammation biomarker Interleukin-6 (IL-6), a cytokine and mediator of inflammation, due to sub-concussion injury from baseline to predetermined measurement time points. IL-6 is measured in picograms per milliliter (pg/ml) | Baseline; then once a month until the end of the study, up to 8 months. |
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