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Prevention of Alcohol Intolerance

NCT ID: NCT01845220

Last Updated: 2017-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Sensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Broccoli Sprout Extract

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

Group Type ACTIVE_COMPARATOR

Broccoli Sprout Extract

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

80% acetone

Interventions

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Broccoli Sprout Extract

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

Intervention Type DRUG

Placebo

80% acetone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* recent skin abnormalities /tanning
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00081276

Identifier Type: -

Identifier Source: org_study_id