Alcohol IntoleranceNCT07802613
ALDH2 rs671, Alcohol Use, and Health Education in University Students
A study testing Individual ALDH2 Genotype Feedback and Standardized Alcohol Health Education in people with Alcohol Intolerance and Alcohol Drinking in College, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Intolerance, Alcohol Drinking in College, Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
- What is being tested?
- Individual ALDH2 Genotype Feedback and Standardized Alcohol Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jan 2022to 24 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently enrolled as a student at National Taiwan University
- Aged 18 to 65 years
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between rs671 Polymorphism and Attitudes and Behaviors Toward Drinking and Effectiveness of Health Education
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.
- Conditions
- Alcohol Intolerance, Alcohol Drinking in College, Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
- Being tested
- Individual ALDH2 Genotype Feedback, Standardized Alcohol Health Education
- Keywords
- ALDH2, rs671, ALDH2 deficiency, Genetic Testing, health education, drinking behavior, East Asian population, college students
- Medical subject headings
- Alcohol Drinking in College, Health Education, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual ALDH2 Genotype FeedbackBehavioural
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.
Standardized Alcohol Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Individual ALDH2 Genotype Feedback; Behavioral: Standardized Alcohol Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to one month after receipt of genotype feedback and health education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start9 Jan 2022
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol IntoleranceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Hsiu Kuo, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802613
- Sponsor's protocol ID
- 202109064RINB
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between rs671 Polymorphism and Attitudes and Behaviors Toward Drinking and Effectiveness of Health Education
- ClinicalTrials.gov ID
- NCT07802613
- Acronym / sponsor ID
- 202109064RINB
- Conditions
- Alcohol Intolerance, Alcohol Drinking in College, Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
- Keywords
- ALDH2, rs671, ALDH2 deficiency, Genetic Testing, health education, drinking behavior, East Asian population, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Genotype Feedback and Health Education | Experimental | Behavioral: Individual ALDH2 Genotype Feedback, Behavioral: Standardized Alcohol Health EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently enrolled as a student at National Taiwan University
- Aged 18 to 65 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual ALDH2 Genotype FeedbackParticipants 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. | Behavioural | Genotype Feedback and Health Education |
| Standardized Alcohol Health EducationAll 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. | Behavioural | Genotype Feedback and Health Education |
Primary outcome
Change From Baseline in Drinking Frequency at One Month
Time frame: Baseline to one month after receipt of genotype feedback and health education
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.
Change From Baseline in Alcohol Consumption per Drinking Occasion at One Month
Time frame: Baseline to one month after receipt of genotype feedback and health education
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.
Change From Baseline in Drinking Attitude Score at One Month
Time frame: Baseline to one month after receipt of genotype feedback and health education
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.
Change From Baseline in Alcohol Intolerance Knowledge Score at One Month
Time frame: Baseline to one month after receipt of genotype feedback and health education
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Po-Hsiu Kuo, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual ALDH2 Genotype Feedback and Standardized Alcohol Health Education in people with Alcohol Intolerance and Alcohol Drinking in College, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Drinking Frequency at One Month (time frame: Baseline to one month after receipt of genotype feedback and health education). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.