Phase 2
N=12
Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers
Sports Concussion
Bottom Line
View on ClinicalTrials.gov: NCT01321151 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. — 1.57; 1.24 AST/ALT ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Resveratrol (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. |
— | — |
| PRIMARY Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. |
— | — |
| SECONDARY Functional Connectivity in Concussed Boxers |
— | — |
| SECONDARY Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance |
— | — |
| SECONDARY Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance |
— | — |
| SECONDARY Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance |
— | — |
Summary
Sports-related concussions are a serious problem in football, boxing, and other full contact sports. After experiencing consecutive concussions, there is an increase in neurological deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this increase in brain damage, novel strategies need to be developed to protect athletes that are participating in these full contact sports. The purpose of this study is to elucidate whether resveratrol decreases brain injury and improves brain function after experiencing a concussion in boxers.
Eligibility Criteria
Inclusion Criteria
- Boxers between the ages 18-35 years old
- Both men and women
- Boxers with an estimated concussion (Mild and Moderate) as estimated by the on-site physician or athletic trainer
- Subject has provided full written informed consent prior to the performance of any protocol-specified procedure
Exclusion Criteria
- Immediate hospitalization for sports-related concussion (Severe Concussion)
- Known inclusion in an interventional clinical trial
- Patients with metal implants that would interfere with the MRI scan
- Known anemia
- Known Pregnancy
- Known history of alcohol/drug abuse
Data sourced from ClinicalTrials.gov (NCT01321151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.