Alcohol Sensitivity
Conditions
Keywords
Broccoli sprouts, alcohol sensitivity, sulforaphane, alcohol metabolism, in the Asian Community
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.
Interventions
150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge
DRUGPlacebo
80% acetone
Sponsors
Johns Hopkins University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-70 years old, * sensitive to alcohol on the skin, Japanese
Exclusion criteria
* recent skin abnormalities /tanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Area of Skin Erythema (Skin Redness) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Total number of subjects is 30. Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions. Thus, 60 skin areas will be randomized.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 34 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 30 | 5 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: mean up to 2 hours
Population: Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Broccoli Sprout Extract | Mean Area of Skin Erythema (Skin Redness) | 3.968 centimeters^2 |
| Placebo | Mean Area of Skin Erythema (Skin Redness) | 1.739 centimeters^2 |