Healthy AdultNCT07392775
ALDH2 Genetic Testing in East Asian Community
A study testing Genetic Test Results Return and Alcohol Flushing Education in people with Healthy Adult and Flushing, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2*2 and ADH1B*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Flushing
- What is being tested?
- Genetic Test Results Return and Alcohol Flushing Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Self-identified as East Asian and/or East Asian American
- Flush when they drink alcohol or have a family member who flushes when they drink
- Able to read and speak English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Jennifer L Young, PhD, 6085137862, jennifer.young1@northwestern.edu
About this study
Official title: A Community-Based Approach for ALDH2 Genetic Testing in East Asian Americans
The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2*2 and ADH1B*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. The main questions it aims to answer are:
- Is providing education plus ALDH2*2/ADH1B*2 genetic testing feasible and acceptable in a clinical care context?
- Does receiving genetic testing results plus education lead to changes in modifiable health behaviors compared with education alone? Researchers will compare education plus genetic testing (intervention arm) to education only (control arm) to see if adding genetic testing improves feasibility/acceptability and supports health behavior change.
Read more
Participants will:
- Complete an education module about alcohol flushing and ALDH2/ADH1B
- Be randomized to either: (A) Receive genetic testing for ALDH2*2 and ADH1B*2 with results disclosure, or (B) Receive education only.
- Complete follow-up measures about feasibility, acceptability, and modifiable health behaviors
Read the detailed description
Alcohol flushing syndrome affects an estimated >500 million individuals worldwide and is strongly associated with functional variants in alcohol metabolism genes, particularly ALDH2 (e.g., ALDH2*2) and ADH1B (e.g., ADH1B*2). ALDH2*2 reduces aldehyde dehydrogenase activity, contributing to acetaldehyde accumulation and is associated with increased risk for alcohol-related morbidity, including certain cancers and cardiometabolic outcomes. Despite the public health relevance, ALDH2/ADH1B implementation in clinical care remains limited, and evidence-based strategies are needed to support equitable and ethical adoption, especially for populations underrepresented in genomics research. This study will engage the East Asian American community to evaluate implementation strategies for ALDH2*2 and ADH1B*2 genetic testing and education in clinical settings and to examine the behavioral impact of returning genetic risk information. Using a pragmatic, randomized comparative effectiveness pilot design, East Asian American adults who self-report alcohol flushing and/or a family history of flushing will be randomized to either: (1) education plus ALDH2*2/ADH1B*2 genetic testing with genotype-informed result disclosure, or (2) education alone. Primary outcomes are feasibility and acceptability of the testing-and-education approach; secondary outcomes include changes in modifiable health behaviors (e.g., alcohol-related decision-making) following education with or without genetic result return. Findings will inform scalable implementation pathways and contribute to equitable integration of genomic testing into routine care for populations experiencing healthcare disparities.
- Conditions
- Healthy Adult, Flushing
- Being tested
- Genetic Test Results Return, Alcohol Flushing Education
- Keywords
- East Asian, Alcohol Flushing, ALDH2, ADH1B, Esophageal Cancer, Genetic Testing, Alzheimer's Disease, Cardiovascular Disease
- Medical subject headings
- Flushing, Esophageal Neoplasms, Alzheimer Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic Test Results ReturnBehavioural
Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)
Alcohol Flushing EducationBehavioural
Administering alcohol flushing educational module.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Flushing Education Only | Active comparator | Not described Receives: Behavioral: Alcohol Flushing Education |
| Alcohol Flushing Education AND Genetic Testing | Experimental | Not described Receives: Behavioral: Genetic Test Results Return; Behavioral: Alcohol Flushing Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Alcohol Flushing Genetic Testing in Primary Care
Feasibility of Intervention Measure (FIM) will be administered to primary care clinicians to measure the extent to which alcohol flushing genetic testing can be successfully used or carried out within a primary care setting. Post-intervention, we will quantitatively assess feasibility of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Feasibility of Intervention Measure (FIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is feasible.
Measured: From enrollment to the end of data collection at 8 weeks.
Secondary outcomes (2)
Acceptability of Alcohol Flushing Genetic Testing in Primary Care
Acceptability of Intervention Measure (AIM) assess how agreeable, palatable, or satisfactory alcohol flushing genetic testing is to primary care clinicians. Post-intervention, we will quantitatively assess acceptability of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Acceptability of Intervention Measure (AIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is acceptable.
Measured: From enrollment to the end of data collection at 8 weeks.
Change(s) in Alcohol Consumption
Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received. This results in 3 alcohol outcome measurements total for both arms of the study.
Measured: Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jennifer Young, Northwestern University
- Investigators
- Jennifer L Young, PhD, Principal investigator, Northwestern U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392775
- Sponsor's protocol ID
- STU00222224
- Other IDs
- 1K01HL173859-01
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent language approved by IRB board did not include broad data sharing AND IDP may be identifiable.
Publications
Zhang LL, Wang YQ, Fu B, Zhao SL, Kui Y. Aldehyde dehydrogenase 2 (ALDH2) polymorphism gene and coronary artery disease risk: a meta-analysis. Genet Mol Res. 2015 Dec 28;14(4):18503-14. doi: 10.4238/2015.December.23.38.
PubMed 26782498Yasue H, Mizuno Y, Harada E. Association of East Asian Variant Aldehyde Dehydrogenase 2 Genotype (ALDH2*2*) with Coronary Spasm and Acute Myocardial Infarction. Adv Exp Med Biol. 2019;1193:121-134. doi: 10.1007/978-981-13-6260-6_7.
PubMed 31368101Xu YL, Hu YY, Li JW, Zhou L, Li L, Niu YM. Aldehyde dehydrogenase 2 rs671G>A polymorphism and ischemic stroke risk in Chinese population: a meta-analysis. Neuropsychiatr Dis Treat. 2019 Apr 23;15:1015-1029. doi: 10.2147/NDT.S196175. eCollection 2019.
PubMed 31114208Ding JH, Li SP, Cao HX, Wu JZ, Gao CM, Liu YT, Zhou JN, Chang J, Yao GH. Alcohol dehydrogenase-2 and aldehyde dehydrogenase-2 genotypes, alcohol drinking and the risk for esophageal cancer in a Chinese population. J Hum Genet. 2010 Feb;55(2):97-102. doi: 10.1038/jhg.2009.129. Epub 2009 Dec 11.
PubMed 20010786Chen J, Huang W, Cheng CH, Zhou L, Jiang GB, Hu YY. Association Between Aldehyde dehydrogenase-2 Polymorphisms and Risk of Alzheimer's Disease and Parkinson's Disease: A Meta-Analysis Based on 5,315 Individuals. Front Neurol. 2019 Mar 28;10:290. doi: 10.3389/fneur.2019.00290. eCollection 2019.
PubMed 30984100
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Approach for ALDH2 Genetic Testing in East Asian Americans
- ClinicalTrials.gov ID
- NCT07392775
- Acronym / sponsor ID
- STU00222224
- Conditions
- Healthy Adult, Flushing
- Keywords
- East Asian, Alcohol Flushing, ALDH2, ADH1B, Esophageal Cancer, Genetic Testing, Alzheimer's Disease, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 6 Feb 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.
The goal of this clinical trial is to learn whether education plus genetic testing for ALDH2*2 and ADH1B*2 is feasible and acceptable and whether it influences modifiable health behaviors in East Asian American adults who experience alcohol flushing when they drink alcohol or have a family history of flushing. The main questions it aims to answer are:
- Is providing education plus ALDH2*2/ADH1B*2 genetic testing feasible and acceptable in a clinical care context?
- Does receiving genetic testing results plus education lead to changes in modifiable health behaviors compared with education alone? Researchers will compare education plus genetic testing (intervention arm) to education only (control arm) to see if adding genetic testing improves feasibility/acceptability and supports health behavior change.
Participants will:
- Complete an education module about alcohol flushing and ALDH2/ADH1B
- Be randomized to either: (A) Receive genetic testing for ALDH2*2 and ADH1B*2 with results disclosure, or (B) Receive education only.
- Complete follow-up measures about feasibility, acceptability, and modifiable health behaviors
Detailed description
Alcohol flushing syndrome affects an estimated >500 million individuals worldwide and is strongly associated with functional variants in alcohol metabolism genes, particularly ALDH2 (e.g., ALDH2*2) and ADH1B (e.g., ADH1B*2). ALDH2*2 reduces aldehyde dehydrogenase activity, contributing to acetaldehyde accumulation and is associated with increased risk for alcohol-related morbidity, including certain cancers and cardiometabolic outcomes. Despite the public health relevance, ALDH2/ADH1B implementation in clinical care remains limited, and evidence-based strategies are needed to support equitable and ethical adoption, especially for populations underrepresented in genomics research. This study will engage the East Asian American community to evaluate implementation strategies for ALDH2*2 and ADH1B*2 genetic testing and education in clinical settings and to examine the behavioral impact of returning genetic risk information. Using a pragmatic, randomized comparative effectiveness pilot design, East Asian American adults who self-report alcohol flushing and/or a family history of flushing will be randomized to either: (1) education plus ALDH2*2/ADH1B*2 genetic testing with genotype-informed result disclosure, or (2) education alone. Primary outcomes are feasibility and acceptability of the testing-and-education approach; secondary outcomes include changes in modifiable health behaviors (e.g., alcohol-related decision-making) following education with or without genetic result return. Findings will inform scalable implementation pathways and contribute to equitable integration of genomic testing into routine care for populations experiencing healthcare disparities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Flushing Education Only | Active comparator | Behavioral: Alcohol Flushing Education |
| Alcohol Flushing Education AND Genetic Testing | Experimental | Behavioral: Genetic Test Results Return, Behavioral: Alcohol Flushing Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Self-identified as East Asian and/or East Asian American
- Flush when they drink alcohol or have a family member who flushes when they drink
- Able to read and speak English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Genetic Test Results ReturnReturning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B) | Behavioural | Alcohol Flushing Education AND Genetic Testing |
| Alcohol Flushing EducationAdministering alcohol flushing educational module. | Behavioural | Alcohol Flushing Education AND Genetic Testing, Alcohol Flushing Education Only |
Primary outcome
Feasibility of Alcohol Flushing Genetic Testing in Primary Care
Time frame: From enrollment to the end of data collection at 8 weeks.
Feasibility of Intervention Measure (FIM) will be administered to primary care clinicians to measure the extent to which alcohol flushing genetic testing can be successfully used or carried out within a primary care setting. Post-intervention, we will quantitatively assess feasibility of ALDH2 education and genetic testing via 1 questionnaire (4 items total): Feasibility of Intervention Measure (FIM). This 4-item psychometrically-validated measure captures the extent to which individuals believe an implementation strategy is feasible.
2 secondary outcomes
Acceptability of Alcohol Flushing Genetic Testing in Primary Care
Time frame: From enrollment to the end of data collection at 8 weeks.
Change(s) in Alcohol Consumption
Time frame: Alcohol consumption outcome measurements at baseline and one month after educational modules are shared AND after genetic testing results are received.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 26782498Zhang LL, Wang YQ, Fu B, Zhao SL, Kui Y. Aldehyde dehydrogenase 2 (ALDH2) polymorphism gene and coronary artery disease risk: a meta-analysis. Genet Mol Res. 2015 Dec 28;14(4):18503-14. doi: 10.4238/2015.December.23.38.
- Background: PubMed 31368101Yasue H, Mizuno Y, Harada E. Association of East Asian Variant Aldehyde Dehydrogenase 2 Genotype (ALDH2*2*) with Coronary Spasm and Acute Myocardial Infarction. Adv Exp Med Biol. 2019;1193:121-134. doi: 10.1007/978-981-13-6260-6_7.
- Background: PubMed 31114208Xu YL, Hu YY, Li JW, Zhou L, Li L, Niu YM. Aldehyde dehydrogenase 2 rs671G>A polymorphism and ischemic stroke risk in Chinese population: a meta-analysis. Neuropsychiatr Dis Treat. 2019 Apr 23;15:1015-1029. doi: 10.2147/NDT.S196175. eCollection 2019.
- Background: PubMed 20010786Ding JH, Li SP, Cao HX, Wu JZ, Gao CM, Liu YT, Zhou JN, Chang J, Yao GH. Alcohol dehydrogenase-2 and aldehyde dehydrogenase-2 genotypes, alcohol drinking and the risk for esophageal cancer in a Chinese population. J Hum Genet. 2010 Feb;55(2):97-102. doi: 10.1038/jhg.2009.129. Epub 2009 Dec 11.
- Background: PubMed 30984100Chen J, Huang W, Cheng CH, Zhou L, Jiang GB, Hu YY. Association Between Aldehyde dehydrogenase-2 Polymorphisms and Risk of Alzheimer's Disease and Parkinson's Disease: A Meta-Analysis Based on 5,315 Individuals. Front Neurol. 2019 Mar 28;10:290. doi: 10.3389/fneur.2019.00290. eCollection 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Consent language approved by IRB board did not include broad data sharing AND IDP may be identifiable.
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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.
Jennifer L Young, PhD principal investigator
Northwestern U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Test Results Return and Alcohol Flushing Education in people with Healthy Adult and Flushing, run by Northwestern University at 1 site in United States.
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 4 inclusion and 0 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: opening soon, as of the sponsor's last update on 28 Oct 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiona Y Seung, MS (2064538538, fiona.seung@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Alcohol Flushing Genetic Testing in Primary Care (time frame: From enrollment to the end of data collection at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07392775, which also lists 5 linked publications.
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 28 Oct 2026.