Alcohol Metabolism and Disease Risk in Asians

Healthy Clinical Trial

— R21AA28365  

Official title:

Alcohol Metabolism and Disease Risk in Asians: Examining the Impact of Personalized Phenotypic/Genotypic Feedback and Motivational Processes on Early Drinking Trajectories

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967599
• Other study ID #: HS-20-00814
• Status: Completed
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: April 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary pathway of alcohol metabolism involves two main enzymes, alcohol and aldehyde dehydrogenase. Several genes that encode these enzymes have variants that alter the rate of alcohol metabolism and increase levels of acetaldehyde. The variant ALDH2*2 allele is associated with the flushing response (i.e., Asian glow) and is found almost exclusively in individuals of east Asian descent. Although having variant ALDH2 alleles is protective against heavy drinking and alcohol use disorders, for those who do drink, these variants also are associated with elevations in risk for several health problems. The premise of this study is that we can affect early drinking behavior through personalized communication about these health-related risks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

Inclusion Criteria:

• All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese).

• Half of the sample will be incoming first-year undergraduates

• Half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol peak consumption	Drinking quantity on heaviest drinking day	Baseline through 10-months post-intervention
Secondary	Alcohol frequency of consumption	Number of drinking days	Baseline through 10-months post-intervention
Secondary	Alcohol weekend consumption	Weekend quantity of alcohol consumed	Baseline through 10-months post-intervention
Secondary	Alcohol consumption	Total quantity of alcohol consumed	Baseline through 10-months post-intervention
Secondary	Non-drinker	Non-drinker will be assessed at baseline with RESPONSE: N/A, I have never had more than sips or tastes of alcohol to the QUESTION: How old were you when you first started drinking, not counting small sips or tastes of alcohol?, and 2) in all follow-up surveys with RESPONSE: never to the QUESTION: How old were you when you had your first drink of alcohol, not counting small sips or tastes of alcohol?	Baseline through 10-months post-intervention
Secondary	Flush cure use	Proportion of time use products to reduce flushing when drinking	Baseline through 10-months post-intervention