Genetic Testing + Education for Flushing

FY
JL
Overseen ByJennifer L Young, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genetic testing, combined with education, can assist East Asian American adults who experience alcohol flushing (redness and warmth in the skin after drinking) or have a family history of it. Researchers aim to determine if this approach is practical and whether it encourages changes in health habits. Participants will receive either educational materials alone or both education and ALDH2 genetic testing to assess if knowing their genetic results influences their health management. This trial suits East Asian American adults who notice skin flushing when they drink or have relatives who do. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could lead to improved health management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this genetic testing and education protocol is safe?

Research has shown that genetic testing for ALDH2 and ADH1B is safe. Previous studies have identified individuals who experience alcohol flushing, a common reaction in East Asian communities, through this testing. The procedure is generally well-tolerated, with no major side effects reported. It involves checking a person's genes for variants that cause flushing when drinking alcohol.

The genetic testing itself poses no safety concerns. It is non-invasive, requiring no surgery or intrusive methods. Participants typically provide a saliva or blood sample for the test. Studies have focused on how people change their health habits after learning their genetic information, rather than any negative effects from the testing process. This suggests that the genetic testing method is safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the trial on ALDH2 genetic testing for alcohol flushing because it offers a personalized approach to understanding and managing the condition. Unlike traditional methods that mainly focus on educating individuals about alcohol flushing, this trial combines education with genetic testing to pinpoint the ALDH2 gene variant responsible for this reaction. By identifying specific genetic factors, it could lead to more tailored lifestyle recommendations and interventions, ultimately improving patient outcomes. This innovative approach emphasizes precision in treatment, which is a significant step forward from the one-size-fits-all educational strategies currently available.

What evidence suggests that this trial's treatments could be effective for alcohol flushing?

Research has shown that genetic testing for ALDH2 and ADH1B can identify individuals who might experience alcohol flushing, a common reaction in East Asian populations. This flushing occurs because certain gene variations cause a buildup of acetaldehyde, a substance produced when the body breaks down alcohol. One study found that this genetic testing is 84.8% accurate in identifying those likely to experience flushing and 82.3% accurate in ruling out those who won't. In this trial, participants will receive either Alcohol Flushing Education only or both Alcohol Flushing Education and Genetic Testing. By knowing their genetic makeup, individuals can better understand their risk and may choose to adjust their drinking habits. This knowledge could lead to healthier choices and fewer alcohol-related issues.26789

Who Is on the Research Team?

JL

Jennifer L Young, PhD

Principal Investigator

Northwestern U

Are You a Good Fit for This Trial?

This trial is for East Asian American adults who experience alcohol flushing or have a family history of it. It's focused on whether adding genetic testing to education about alcohol flushing can change health behaviors.

Inclusion Criteria

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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education Module

Participants complete an education module about alcohol flushing and ALDH2/ADH1B

1 week
1 visit (virtual)

Intervention

Participants are randomized to either receive genetic testing with results disclosure or education only

4 weeks
1 visit (in-person or virtual)

Follow-up

Participants complete follow-up measures about feasibility, acceptability, and modifiable health behaviors

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • ALDH2 Genetic Testing

Trial Overview

The study tests if providing ALDH2*2/ADH1B*2 genetic testing along with education is more effective than just education in influencing health behavior changes related to rosacea, Alzheimer's, esophageal cancer, and cardiovascular disease.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Alcohol Flushing Education AND Genetic TestingExperimental Treatment2 Interventions
Group II: Alcohol Flushing Education OnlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Northwestern University Feinberg School of Medicine

Collaborator

Trials
42
Recruited
15,500+

Citations

Genetic influences on alcohol flushing in East Asian populations

We identified variants in the region of ALDH2 strongly associated with alcohol flushing, replicating previous studies conducted in East Asian populations.

ALDH2 Genetic Testing in East Asian Community

Alcohol flushing syndrome affects an estimated >500 million individuals worldwide and is strongly associated with functional variants in ...

Alcohol Flushing, Alcohol and Aldehyde Dehydrogenase ...

When current or former flushing individuals were considered to have inactive ALDH2, the sensitivity and specificity of the test were 84.8% and 82.3%,, ...

Gene Therapy Correction of Aldehyde Dehydrogenase 2 ...

Aldehyde dehydrogenase 2 (ALDH2) deficiency causes “Asian flush syndrome,” presenting as alcohol-induced facial flushing, tachycardia, nausea, and headaches.

Asian Flush and Easily Drunk: The Genetics of Alcohol ...

A variation in this gene increases ADH enzyme activity, meaning alcohol is broken down into acetaldehyde at a much faster rate.

ALDH2 deficiency and alcohol intake in the U.S. - PMC

The prevalence of ALDH2 deficiency was determined by examining rs671 genotype among 311,290 participants within the All of Us Research Program. Relationships ...

Genetic Testing for Alcohol Flushing (AIAC Trial)

Eighty percent of those who were heterozygous and 28% of those who were homozygous ALDH2*1 reported flush symptoms after drinking alcohol.

Aldehyde dehydrogenase 2 genotypes, alcohol flushing ...

Eighty percent of those who were heterozygous and 28% of those who were homozygous ALDH2*1 reported flush symptoms after drinking alcohol. Twenty-nine percent ...

Alcohol, 'Asian glow' mutation may contribute to Alzheimer's ...

A common mutation in a key enzyme involved in alcohol metabolism increases damage in cells from patients with Alzheimer's disease and in mice.