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Prevention of Alcohol Intolerance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Paul Talalay, M.D., Johns Hopkins University.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Paul Talalay, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01845220
First received: April 23, 2013
Last updated: December 3, 2014
Last verified: December 2014
  Purpose
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 Intervention Phase
Alcohol Sensitivity Drug: Broccoli Sprout Extract Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Paul Talalay, M.D., Johns Hopkins University:

Primary Outcome Measures:
  • Skin Erythema (Skin redness) [ Time Frame: 30 minutes after alcohol skin challenge and every 30 minutes for at least 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.


Estimated Enrollment: 10
Study Start Date: April 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845220

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Paul Talalay, M.D.
  More Information

Responsible Party: Paul Talalay, M.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01845220     History of Changes
Other Study ID Numbers: 81276
Study First Received: April 23, 2013
Last Updated: December 3, 2014

Keywords provided by Paul Talalay, M.D., Johns Hopkins University:
Broccoli sprouts
alcohol sensitivity
sulforaphane
alcohol metabolism
in the Asian Community

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017