Prevention of Alcohol Intolerance

NCT01845220 | Completed Phase 2 Results

• 1 other identifier: NA_00081276
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Sensitivity

Keywords

Broccoli sprouts; alcohol sensitivity; sulforaphane; alcohol metabolism; in the Asian Community

Outcome Measures

Primary Outcomes (1)

• 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.

  mean up to 2 hours

Study Arms (2)

Broccoli Sprout Extract

ACTIVE COMPARATOR

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

Drug: Broccoli Sprout Extract

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Broccoli Sprout Extract DRUG

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

Broccoli Sprout Extract

Placebo DRUG

80% acetone

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• sensitive to alcohol on the skin, Japanese

You may not qualify if:

• recent skin abnormalities /tanning

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Results Point of Contact

• Title: Jed W. Fahey, Sc.D.
• Organization: Johns Hopkins University

jfahey@jhmi.edu

4106142607

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-08

Locations

US (1)