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Prevention of Alcohol Intolerance

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ClinicalTrials.gov Identifier: NCT01845220
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Alcohol Sensitivity
Interventions Drug: Broccoli Sprout Extract
Drug: Placebo
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Broccoli Sprout Extract Placebo
Hide Arm/Group Description

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Placebo: 80% acetone

Period Title: Overall Study
Number of participants Number of units (skin area) Number of participants Number of units (skin area)
Started 30 30 30 30
Completed 30 30 30 30
Not Completed 0 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description

Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized.

Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge Placebo Comparator.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
Total number of subjects is 30 -- each subject is own control. "Skin area" is the unit of analysis, thus there are both broccoli sprout extract treated and placebo treated skin areas on each subject (totalling 60 skin areas).
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
34
(25 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
16
  53.3%
Male
14
  46.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
30
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Mean Area of Skin Erythema (Skin Redness)
Hide Description For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.
Time Frame mean up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.
Arm/Group Title Broccoli Sprout Extract Placebo
Hide Arm/Group Description:

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Placebo: 80% acetone

Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: centimeters^2
3.968
(2.900 to 5.036)
1.739
(0.912 to 2.567)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Broccoli Sprout Extract Placebo
Hide Arm/Group Description

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Broccoli Sprout Extract: 150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

Placebo: 80% acetone

All-Cause Mortality
Broccoli Sprout Extract Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Broccoli Sprout Extract Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Broccoli Sprout Extract Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/30 (16.67%)      5/30 (16.67%)    
Skin and subcutaneous tissue disorders     
mild itchy skin or erythema *  5/30 (16.67%)  5 5/30 (16.67%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jed W. Fahey, Sc.D.
Organization: Johns Hopkins University
Phone: 4106142607
EMail: jfahey@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01845220    
Other Study ID Numbers: NA_00081276
First Submitted: April 23, 2013
First Posted: May 3, 2013
Results First Submitted: July 5, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017