Prevention of Alcohol Intolerance

August 31, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • recent skin abnormalities /tanning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
mean up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00081276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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