Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Each year, approximately 3 million sports-related concussions occur in athletes. Only about 5% of these concussions are treated in the hospital setting. To date, there are no effective interventions used at decreasing the levels of oxidant injury and inflammation within these athletes. The standard form of care in these athletes is usually rest and light exercise for 1 -2 weeks, before returning to the sport. Within this brain injury population, administration of a neuro-protectant agent immediately following the concussion may alleviate or prevent secondary injury and subsequent development of long-term cognitive deficits such as Chronic Traumatic Encephalopathy (CTE) and Dementia pugilistica (DP). Since sports-related concussions are a serious problem in our youth, by using safe interventions, we believe that the levels of oxidant injury and brain inflammation will be decreased. In addition, these neuro-protective agents may improve cognition in these boxers, and decrease the incidence of DP.
Following brain injury, the secondary injury that immediately follows consists of heightened damage by oxygen radicals, which in turn damages vital lipids, proteins, and nucleic acids. This damage is exacerbated by highly acidic conditions with lead to the release of iron and the production of more harmful oxygen radicals. An increase in these oxygen radicals has been observed from minutes to hours within the primary injury. In addition, there is an increase in inflammation as well as excitotoxicity in the brain after traumatic injury. To combat this secondary injury, the use of anti-oxidants in individuals is warranted to decrease the amount of brain damage and cognitive decline after experiencing a severe brain injury. For example, resveratrol (3,5,4'-trihydroxystilbene) which is a polyphenol compound that is commonly found in grapes, is a nutritional supplement with anti-oxidant and anti-inflammatory properties with great promise for treating TBI secondary injury. A number of researchers have demonstrated that resveratrol protect multiple organs (heart, kidney, brain) from ischemia after injury. With respect to the brain, resveratrol has been shown to protect from oxidative stress, Huntington's disease, and stroke. Additionally, following TBI in various animal models, resveratrol protected from severe brain injuries. Results from these brain studies suggest that resveratrol protects from a plethora of injuries and may afford protection from secondary injury in individuals suffering from a severe brain injury.
In this pilot clinical trial, boxers (n=30) will be consented to participate in this study prior to engaging in a boxing match. The concussion history will be collected before enrolling. Baseline cognitive testing and magnetic resonance imaging (MRI) scan will be performed to obtain both structural and functional data. Only 12 boxers that have a concussion will be enrolled in this study. After participating in the boxing match, if the boxer has been diagnosed with having a concussion by the ringside physician, the boxers will be treated with an oral dose of the active trans-resveratrol (500 mg) or placebo within 2 hours of completion of the boxing match. The boxer will be treated with either resveratrol or placebo (depending on the randomization schedule) once a day for 30 days. Cognitive testing and MRI scans will be conducted on day 7 after the concussion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Placebo control |
|
| Resveratrol | Experimental | Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. | Liver Function Tests will be conducted on day 7 after concussion. | Day 7 post concussion |
| Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. | Liver Function Tests will be conducted on day 30 after concussion. | 30 Days post concussion |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Connectivity in Concussed Boxers | Functional connectivity magnetic resonance imaging | 30 Days |
| Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joshua W. Gatson, Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury. |
| FG001 | Resveratrol | Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury. |
| BG001 | Resveratrol | Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. | Liver Function Tests will be conducted on day 7 after concussion. | This Outcome measure differs from Outcome measure 1 based on the time frame. In Outcome measure 1, the time frame listed is -'30 Days post concussion' whereas within Outcome measure 2, the time frame listed is -'Day 7 post concussion'. | Posted | Mean | Standard Deviation | AST/ALT ratio | Day 7 post concussion |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Marks, Ph.D. | UT Southwestern Medical Center | 214-648-0882 | megan.marks@utsouthwestern.edu |
Not provided
| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury. |
|
The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct
| 7 days post concussion |
| Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance | The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct | 24-72 hours post concussion |
| Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance | The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct | 30 days post concussion |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Intervention
Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
|
|
| Primary | Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events. | Liver Function Tests will be conducted on day 30 after concussion. | No data was collected for30 days post concussion | Posted | 30 Days post concussion |
|
|
| Secondary | Functional Connectivity in Concussed Boxers | Functional connectivity magnetic resonance imaging | No data was collected for 30 days post concussion | Posted | 30 Days |
|
|
| Secondary | Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance | The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct | Posted | Mean | Standard Deviation | Composite Score | 7 days post concussion |
|
|
|
| Secondary | Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance | The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct | No data was collected for 24-72 hours post concussion | Posted | 24-72 hours post concussion |
|
|
| Secondary | Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance | The reaction time composite score (range 0.5-0.8) is an average of: modules 3,4, 5, then divided by 3.The higher the composite score, the worse the outcomes.
Each modules is measured in percentage correct | No data was collected for 30 days post concussion | Posted | 30 days post concussion |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Resveratrol | Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |