NCT07802613

Brief Summary

Alcohol intolerance is common in East Asian populations and is strongly influenced by the rs671 variant in the ALDH2 gene. This study examined the associations of ALDH2 genotype with drinking behavior and alcohol-related reactions among Taiwanese university students. Participants with previous alcohol exposure underwent rs671 genotyping and received their individual genotype results together with the same standardized health education materials about alcohol intolerance and related health risks. Drinking behavior, knowledge, and attitudes were assessed before and one month after the intervention. The study also evaluated whether facial flushing and rapid heartbeat could help identify ALDH2 deficiency. Changes over the one-month period were evaluated overall and by genotype group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 30, 2026

Last Update Submit

August 30, 2026

Conditions

Keywords

ALDH2rs671ALDH2 deficiencyGenetic Testinghealth educationdrinking behaviorEast Asian populationcollege students

Outcome Measures

Primary Outcomes (4)

  • Change From Baseline in Drinking Frequency at One Month

    Drinking frequency was assessed using a study-specific questionnaire with ordinal response categories reflecting the number of drinking occasions per month. The change score was calculated from the baseline and one-month responses according to the prespecified questionnaire coding.

    Baseline to one month after receipt of genotype feedback and health education

  • Change From Baseline in Alcohol Consumption per Drinking Occasion at One Month

    Alcohol consumption per drinking occasion was assessed using ordinal categories of 1-2, 3-4, or 5 or more alcohol units. One alcohol unit was calculated as \[beverage volume (mL) × alcohol by volume (%)\]/1000. The change score was calculated from the baseline and one-month responses.

    Baseline to one month after receipt of genotype feedback and health education

  • Change From Baseline in Drinking Attitude Score at One Month

    Attitudes toward drinking were assessed using six study-specific statements rated on a five-point Likert scale from strongly disagree to strongly agree. Items were coded according to the prespecified scoring method and summed to produce a total attitude score, with higher scores indicating healthier attitudes toward alcohol use.

    Baseline to one month after receipt of genotype feedback and health education

  • Change From Baseline in Alcohol Intolerance Knowledge Score at One Month

    Knowledge was assessed using a study-specific questionnaire covering alcohol metabolism, symptoms of alcohol intolerance, related health risks, diagnosis, treatment, and prevalence. The total score was calculated from correct responses, with higher scores indicating greater knowledge.

    Baseline to one month after receipt of genotype feedback and health education

Study Arms (1)

Genotype Feedback and Health Education

EXPERIMENTAL

Participants underwent ALDH2 rs671 genotyping and received their individual genotype results together with the same standardized health education materials about alcohol intolerance, alcohol-related reactions, and associated health risks. Drinking behavior, knowledge, and attitudes were assessed at baseline and one month after the intervention.

Behavioral: Individual ALDH2 Genotype FeedbackBehavioral: Standardized Alcohol Health Education

Interventions

Participants underwent ALDH2 rs671 genotyping and received an individual report indicating their rs671 genotype (GG, GA, or AA) and corresponding ALDH2 metabolic status. No individualized health education was provided based on genotype.

Genotype Feedback and Health Education

All participants received the same standardized health education materials concerning alcohol metabolism, symptoms of alcohol intolerance, and health risks associated with alcohol use and ALDH2 deficiency. The educational content was not individualized according to genotype.

Genotype Feedback and Health Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently enrolled as a student at National Taiwan University
  • Aged 18 to 65 years

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Alcohol Drinking in CollegeHealth EducationDrinking Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol DrinkingBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Po-Hsiu Kuo, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This was a single-group, nonrandomized pre-post study. All participants underwent ALDH2 rs671 genotyping, received their individual genotype results and the same standardized health education materials, and completed assessments at baseline and one month after the intervention. Genotype groups were analyzed as naturally occurring subgroups and were not assigned as separate intervention arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 3, 2026

Study Start

January 9, 2022

Primary Completion

May 24, 2022

Study Completion

May 24, 2022

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified participant-level data underlying the findings reported in the published article may be shared, together with the relevant data dictionary. The data may include variables needed to reproduce the reported analyses, such as rs671 genotype, demographic characteristics, alcohol-related reactions, drinking behavior, knowledge, and attitude measures. Direct identifiers will not be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Data requests may be submitted after publication of the primary study results. Data will remain potentially available for as long as they are retained in accordance with institutional and ethical requirements.
Access Criteria
Qualified researchers may submit a written request to the corresponding author describing the research purpose, analysis plan, requested variables, and data-security procedures. Access will require prior approval from the relevant institutional ethics committee, compliance with applicable informed-consent requirements, and execution of an appropriate data-use agreement. Data will not be shared without the required ethical approval and must not be redistributed or used in attempts to identify individual participants.

Locations