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Trial Outcomes & Findings for Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers (NCT NCT01321151)

NCT ID: NCT01321151

Last Updated: 2021-02-11

Results Overview

Liver Function Tests will be conducted on day 7 after concussion.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Day 7 post concussion

Results posted on

2021-02-11

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Resveratrol
Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
Overall Study
STARTED
6
6
Overall Study
COMPLETED
6
6
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Resveratrol to Decrease Acute Secondary Brain Injury Following Sports-Related Concussions in Boxers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sugar Pill
n=6 Participants
Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
Resveratrol
n=6 Participants
Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
Total
n=12 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=93 Participants
6 Participants
n=4 Participants
12 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Continuous
26 years
STANDARD_DEVIATION 5 • n=93 Participants
27 years
STANDARD_DEVIATION 5.3 • n=4 Participants
26 years
STANDARD_DEVIATION 5.15 • n=27 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Sex: Female, Male
Male
6 Participants
n=93 Participants
5 Participants
n=4 Participants
11 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=93 Participants
4 Participants
n=4 Participants
9 Participants
n=27 Participants
Race (NIH/OMB)
White
0 Participants
n=93 Participants
2 Participants
n=4 Participants
2 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
6 participants
n=93 Participants
6 participants
n=4 Participants
12 participants
n=27 Participants

PRIMARY outcome

Timeframe: Day 7 post concussion

Population: 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'.

Liver Function Tests will be conducted on day 7 after concussion.

Outcome measures

Outcome measures
Measure
Sugar Pill
n=6 Participants
Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
Resveratrol
n=6 Participants
Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
Liver Function Testing (Aspartate Transaminase [AST]/Alanine Transaminase [ALT] Ratios) to Screen for Adverse Events.
1.57 AST/ALT ratio
Standard Deviation .4
1.24 AST/ALT ratio
Standard Deviation .3

PRIMARY outcome

Timeframe: 30 Days post concussion

Population: No data was collected for30 days post concussion

Liver Function Tests will be conducted on day 30 after concussion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 Days

Population: No data was collected for 30 days post concussion

Functional connectivity magnetic resonance imaging

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days post concussion

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. 1. Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test 2. Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome. 3. Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome. Each modules is measured in percentage correct

Outcome measures

Outcome measures
Measure
Sugar Pill
n=6 Participants
Placebo control Placebo: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
Resveratrol
n=6 Participants
Intervention Resveratrol: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
Reaction Time Composite as Assessed by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Cognitive Test Performance
.675 Composite Score
Standard Deviation .103
.695 Composite Score
Standard Deviation .179

SECONDARY outcome

Timeframe: 24-72 hours post concussion

Population: No data was collected for 24-72 hours post concussion

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. 1. Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test 2. Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome. 3. Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome. Each modules is measured in percentage correct

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post concussion

Population: No data was collected for 30 days post concussion

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. 1. Average correct reaction time of interference stage of module 3 (X's and O'S) - Measures the number of correctly identified items (total possible correct =12), scoring 0-12. There is 4 trials of this module completed. Measures the average reaction time for correct responses on the interference (distracter) test 2. Average correct reaction time of module 4 (Symbol Match) - Provides the number of correct matches out of 27 when the symbol number pairings are visible. The quicker the response time for each correctly identified symbol match indicates a better outcome. 3. Average correct reaction time of module 5 (Color Match) - is number of correct color matches. The quicker the response time to a correct color match is a better outcome. Each modules is measured in percentage correct

Outcome measures

Outcome data not reported

Adverse Events

Sugar Pill

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Resveratrol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Megan Marks, Ph.D.

UT Southwestern Medical Center

Phone: 214-648-0882

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place