Alcohol Metabolism and Disease Risk in Asians

NCT04967599 | Completed Results

• 1 other identifier: HS-20-00814
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Peak Number of Alcohol Drinks Consumed in a Day

  Drinking quantity (i.e. total number of alcoholic drinks) consumed on heaviest drinking day

  Baseline through 10-months post-intervention (which occurred on 1 day)

Secondary Outcomes (5)

• Number of Drinking Days

  Baseline through 10-months post-intervention (which occurred on 1 day)

• Number of Alcoholic Drinks Consumed on Weekend

  Baseline through 10-months post-intervention (which occurred on 1 day)

• Number of Alcoholic Drinks Consumed Weekly

  Baseline through 10-months post-intervention (which occurred on 1 day)

• Number of Participants Identified as Non-drinkers

  Baseline through 10-months post-intervention (which occurred on 1 day)

• Alcohol Flush Cure Use Rate

  Baseline through 10-months post-intervention (which occurred on 1 day)

Study Arms (3)

Control (CONTROL)

NO INTERVENTION

Participants do not receive PHEN or GENE.

Phenotype Feedback (PHEN)

EXPERIMENTAL

Participants receive the PHEN intervention.

Behavioral: Phenotype Feedback Intervention

Phenotype and Genotype Feedback (PHEN+GENE)

EXPERIMENTAL

Participants receive the PHEN and GENE interventions.

Behavioral: Phenotype Feedback Intervention; Behavioral: Genotype Feedback Intervention

Interventions

Phenotype Feedback Intervention BEHAVIORAL

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.

Also known as: PHEN

Phenotype Feedback (PHEN); Phenotype and Genotype Feedback (PHEN+GENE)

Genotype Feedback Intervention BEHAVIORAL

Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.

Also known as: GENE

Phenotype and Genotype Feedback (PHEN+GENE)

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All participants will be of Asian heritage (i.e. Chinese/Taiwanese, Japanese, Korean, Vietnamese).
• About half of the sample will be incoming first-year undergraduates
• About half of the sample will be current undergraduates who self-report having flushed when they first started drinking alcohol

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Interventions

Genes

Intervention Hierarchy (Ancestors)

Genome Components; Genome; Genetic Structures; Genetic Phenomena

Results Point of Contact

• Title: Susan Luczak, PI of study
• Organization: University of Southern California

luczak@usc.edu

2137402203

Study Officials

• Susan E. Luczak, Ph.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Research)

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 19, 2021
• Study Start: August 18, 2021
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared no later than 2 years after the project end date.
• Access Criteria: De-identified data will be available to eligible researchers, and summary information will be available to the public.

Locations

US (1)