Trial Outcomes & Findings for Alcohol Metabolism and Disease Risk in Asians (NCT NCT04967599)
NCT ID: NCT04967599
Last Updated: 2024-12-24
Results Overview
Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
360 participants
Primary outcome timeframe
Baseline through 10-months post-intervention (which occurred on 1 day)
Results posted on
2024-12-24
Participant Flow
Participants were recruited July to October 2021 as a college student sample in Los Angeles
All 360 participants were assigned to a group.
Participant milestones
| Measure |
Control (CONTROL)
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
120
|
|
Overall Study
COMPLETED
|
85
|
101
|
97
|
|
Overall Study
NOT COMPLETED
|
35
|
19
|
23
|
Reasons for withdrawal
| Measure |
Control (CONTROL)
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
35
|
19
|
23
|
Baseline Characteristics
Alcohol Metabolism and Disease Risk in Asians
Baseline characteristics by cohort
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.7 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
19.1 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
18.6 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
18.8 years
STANDARD_DEVIATION 1.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
115 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
120 participants
n=7 Participants
|
120 participants
n=5 Participants
|
360 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 360 participants were in the baseline assessment, 280 had this outcome in the 10-month follow-up assessment
Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day
Outcome measures
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Peak Number of Alcohol Drinks Consumed in a Day
Baseline
|
3.7 drinks
Standard Deviation 3.5
|
4.2 drinks
Standard Deviation 4.1
|
3.4 drinks
Standard Deviation 3.0
|
|
Peak Number of Alcohol Drinks Consumed in a Day
10-month follow-up
|
3.0 drinks
Standard Deviation 2.9
|
2.8 drinks
Standard Deviation 2.7
|
3.2 drinks
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 360 participants were in the baseline assessment, 279 of whom reported this variable in the 10-month follow-up assessment
Number of days consumed alcohol in the past month
Outcome measures
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Number of Drinking Days
Baseline
|
2.4 days
Standard Deviation 1.8
|
2.3 days
Standard Deviation 1.8
|
2.3 days
Standard Deviation 1.8
|
|
Number of Drinking Days
10-month follow-up
|
2.3 days
Standard Deviation 1.9
|
2.0 days
Standard Deviation 1.8
|
2.2 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 360 participants were in the baseline assessment, 269 of whom reported on this variable in the 10-month follow-up assessment
Alcohol quantity (total number of drinks) consumed on a typical drinking weekend
Outcome measures
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Number of Alcoholic Drinks Consumed on Weekend
Baseline
|
2.7 drinks
Standard Deviation 4.2
|
3.1 drinks
Standard Deviation 4.4
|
2.7 drinks
Standard Deviation 3.6
|
|
Number of Alcoholic Drinks Consumed on Weekend
10-month follow-up
|
2.1 drinks
Standard Deviation 3.8
|
1.9 drinks
Standard Deviation 3.0
|
2.7 drinks
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 360 participants were in the baseline assessment, 269 of whom reported this variable in the 10-month follow-up
Total quantity (i.e. number of drinks) of alcohol consumed in a typical drinking week
Outcome measures
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Number of Alcoholic Drinks Consumed Weekly
Baseline
|
3.2 drinks
Standard Deviation 4.6
|
4.0 drinks
Standard Deviation 5.6
|
2.9 drinks
Standard Deviation 4.1
|
|
Number of Alcoholic Drinks Consumed Weekly
10-month follow-up
|
2.8 drinks
Standard Deviation 5.8
|
2.2 drinks
Standard Deviation 3.4
|
2.7 drinks
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 360 participants were in the baseline assessment, 280 of whom reported on this variable in the 10-month follow-up
Number of Participants Identified as Non-drinkers (i.e. have not had alcohol beyond small sips or tastes)
Outcome measures
| Measure |
Control (CONTROL)
n=120 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=120 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=120 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Number of Participants Identified as Non-drinkers
Baseline
|
14 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants Identified as Non-drinkers
10-month follow-up
|
4 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline through 10-months post-intervention (which occurred on 1 day)Population: 311 participants in the baseline assessment and 220 in the 10-month follow-up assessment were current drinkers and could have used a flush cure (i.e. taken a substance to reduce flushing when drinking alcohol)
Proportion of time used a product to reduce flushing when drinking alcohol
Outcome measures
| Measure |
Control (CONTROL)
n=107 Participants
Participants do not receive PHEN or GENE.
|
Phenotype Feedback (PHEN)
n=101 Participants
Participants receive the PHEN intervention.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
|
Phenotype and Genotype Feedback (PHEN+GENE)
n=103 Participants
Participants receive the PHEN and GENE interventions.
Phenotype Feedback Intervention: Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
Genotype Feedback Intervention: Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
|
|---|---|---|---|
|
Alcohol Flush Cure Use Rate
Baseline · Some of the time used a flush cure
|
7 Participants
|
6 Participants
|
3 Participants
|
|
Alcohol Flush Cure Use Rate
Baseline · Almost never/never used a flush cure
|
97 Participants
|
91 Participants
|
94 Participants
|
|
Alcohol Flush Cure Use Rate
Baseline · Half of the time or more used a flush cure
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Alcohol Flush Cure Use Rate
10-month follow-up · Some of the time used a flush cure
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Alcohol Flush Cure Use Rate
10-month follow-up · Almost never/never used a flush cure
|
61 Participants
|
67 Participants
|
73 Participants
|
|
Alcohol Flush Cure Use Rate
10-month follow-up · Half of the time or more used a flush cure
|
2 Participants
|
5 Participants
|
3 Participants
|
Adverse Events
Control (CONTROL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phenotype Feedback (PHEN)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phenotype and Genotype Feedback (PHEN+GENE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susan Luczak, PI of study
University of Southern California
Phone: 2137402203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place