Phase 2
N=60
Prevention of Alcohol Intolerance
Alcohol Sensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01845220 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Mean Area of Skin Erythema (Skin Redness) — 3.968; 1.739 centimeters^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Broccoli Sprout Extract (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area of Skin Erythema (Skin Redness) |
3.968; 1.739 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18-70 years old,
- sensitive to alcohol on the skin, Japanese
Exclusion Criteria
- recent skin abnormalities /tanning
Data sourced from ClinicalTrials.gov (NCT01845220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.