Back to resultsPrevention of Alcohol Intolerance
Primary Purpose
Alcohol Sensitivity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Broccoli Sprout Extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Sensitivity focused on measuring Broccoli sprouts, alcohol sensitivity, sulforaphane, alcohol metabolism, in the Asian Community
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old,
- sensitive to alcohol on the skin, Japanese
Exclusion Criteria:
- recent skin abnormalities /tanning
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Broccoli Sprout Extract
Placebo
Arm Description
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
Outcomes
Primary Outcome Measures
Mean Area of Skin Erythema (Skin Redness)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01845220
First Posted
April 23, 2013
Last Updated
August 31, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01845220
Brief Title
Prevention of Alcohol Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Sensitivity
Keywords
Broccoli sprouts, alcohol sensitivity, sulforaphane, alcohol metabolism, in the Asian Community
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Broccoli Sprout Extract
Arm Type
Active Comparator
Arm Description
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
Intervention Type
Drug
Intervention Name(s)
Broccoli Sprout Extract
Intervention Description
150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
80% acetone
Primary Outcome Measure Information:
Title
Mean Area of Skin Erythema (Skin Redness)
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-70 years old,
sensitive to alcohol on the skin, Japanese
Exclusion Criteria:
recent skin abnormalities /tanning
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
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Prevention of Alcohol Intolerance
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