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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 Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Sensitivity Drug: Broccoli Sprout Extract Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2014
Actual Primary Completion Date : July 1, 2015
Actual Study Completion Date : July 1, 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Broccoli Sprout Extract
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
 Drug: 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: Placebo
Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.
 Drug: Placebo
80% acetone


Outcome Measures
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Primary Outcome Measures :
  1. Mean Area of Skin Erythema (Skin Redness) [ Time Frame: mean up to 2 hours ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 years old,
  • sensitive to alcohol on the skin, Japanese

Exclusion Criteria:

  • recent skin abnormalities /tanning
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845220


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01845220    
Other Study ID Numbers: NA_00081276
First Posted: May 3, 2013    Key Record Dates
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: August 2017
Keywords provided by Johns Hopkins University:
Broccoli sprouts
alcohol sensitivity
sulforaphane
alcohol metabolism
in the Asian Community
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases