NCT01321151

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

March 21, 2011

Results QC Date

March 1, 2019

Last Update Submit

January 23, 2021

Conditions

Sports Concussion

Keywords

Mild Brain InjuryConcussionsResveratrolBoxersImPACTMRI

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Functional Connectivity in Concussed Boxers

    30 Days

  • Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance

    7 days post concussion

  • Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance

    24-72 hours post concussion

  • Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance

    30 days post concussion

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Resveratrol

EXPERIMENTAL

Intervention

Drug: Resveratrol

Interventions

ResveratrolDRUG

The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.

Resveratrol
PlaceboDRUG

The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.

Sugar Pill

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Immediate hospitalization for sports-related concussion (Severe Concussion)
  • Patients with metal implants that would interfere with the MRI scan
  • Known anemia
  • Known Pregnancy
  • Known history of alcohol/drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Tooth, Impacted

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Results Point of Contact

Title
Megan Marks, Ph.D.
Organization
UT Southwestern Medical Center
megan.marks@utsouthwestern.edu
214-648-0882

Study Officials

  • Joshua W. Gatson, Ph.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 23, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 11, 2021

Results First Posted

February 11, 2021

Record last verified: 2021-01

Locations

US(1)