NCT07392775

Brief 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. The main questions it aims to answer are:

  1. 1.Is providing education plus ALDH2\*2/ADH1B\*2 genetic testing feasible and acceptable in a clinical care context?
  2. 2.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.
  3. 3.Complete an education module about alcohol flushing and ALDH2/ADH1B
  4. 4.Be randomized to either: (A) Receive genetic testing for ALDH2\*2 and ADH1B\*2 with results disclosure, or (B) Receive education only.
  5. 5.Complete follow-up measures about feasibility, acceptability, and modifiable health behaviors

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

January 21, 2026

Last Update Submit

February 4, 2026

Conditions

Healthy AdultFlushing

Keywords

East AsianAlcohol FlushingALDH2ADH1BEsophageal CancerGenetic TestingAlzheimer's DiseaseCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of data collection at 8 weeks.

Secondary Outcomes (2)

  • Acceptability of Alcohol Flushing Genetic Testing in Primary Care

    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.

Study Arms (2)

Alcohol Flushing Education Only

ACTIVE COMPARATOR
Behavioral: Alcohol Flushing Education

Alcohol Flushing Education AND Genetic Testing

EXPERIMENTAL
Behavioral: Genetic Test Results ReturnBehavioral: Alcohol Flushing Education

Interventions

Genetic Test Results ReturnBEHAVIORAL

Returning genetic test results for alcohol flushing genes (i.e., ALDH2, ADH1B)

Alcohol Flushing Education AND Genetic Testing
Alcohol Flushing EducationBEHAVIORAL

Administering alcohol flushing educational module.

Alcohol Flushing Education AND Genetic TestingAlcohol Flushing Education Only

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

  • 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.

    PMID: 26782498BACKGROUND

  • Yasue 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.

    PMID: 31368101BACKGROUND

  • Xu 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.

    PMID: 31114208BACKGROUND

  • Ding 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.

    PMID: 20010786BACKGROUND

  • Chen 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.

    PMID: 30984100BACKGROUND

Related Links

MeSH Terms

Conditions

FlushingEsophageal NeoplasmsAlzheimer DiseaseCardiovascular Diseases

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Jennifer L Young, PhD

    Northwestern U

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Y Seung, MS

CONTACT

2064538538fiona.seung@northwestern.edu

Jennifer L Young, PhD

CONTACT

6085137862jennifer.young1@northwestern.edu

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
Assistant Professor

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Consent language approved by IRB board did not include broad data sharing AND IDP may be identifiable.

Locations

US(1)