Genetic Testing for Alcohol Flushing

(AIAC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if awareness of the health risks associated with alcohol flushing—a reaction some people experience when drinking alcohol—can alter drinking habits. Participants will undergo testing for an ALDH2 gene mutation, linked to alcohol flushing, through a process called ALDH2 genotyping. Some participants will receive their results immediately, while others will learn them after the trial concludes. This study suits English-speaking adults interested in understanding how their genetics might influence their drinking. As an unphased trial, it provides a unique opportunity to explore personal genetic insights without the constraints of traditional clinical trial phases.

Do I need to stop my current medications for this trial?

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

What prior data suggests that ALDH2 Genotyping is safe?

Research on ALDH2 genotyping shows that this test helps in understanding how genes affect alcohol flushing, which causes facial redness after drinking alcohol. Studies have not reported any safety issues with the genetic testing itself. The goal is to determine if individuals change their drinking habits after learning their genetic results.

While specific safety data for the genotyping process is not available, it is generally considered safe, similar to other common genetic tests used for health insights. Thus, no known risks or side effects are associated with the testing process itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the genetic testing for alcohol flushing because it offers a personalized approach to managing this condition. Unlike current methods, which primarily focus on managing symptoms after they occur, this approach uses ALDH2 genotyping to identify individuals with a genetic mutation causing alcohol flushing. By revealing this information, people can make informed decisions about their alcohol consumption. This proactive strategy could potentially reduce the risk of adverse health effects associated with alcohol flushing, making it a groundbreaking step towards personalized medicine.

What evidence suggests that ALDH2 genotyping is effective for raising awareness of alcohol flushing?

Research has shown that people with certain variations in the ALDH2 gene, such as the ALDH2*2 type, tend to drink less alcohol and have a lower risk of alcohol-related cancers. In this trial, participants will be divided into two groups: one group will learn their genotype, while the other will remain uninformed until after the study. Studies have found that when people discover their ALDH2 gene type, especially if it indicates low ALDH2 activity, they often reduce their alcohol consumption. For example, individuals with the ALDH2*1/*2 gene type who received personalized feedback about their genetic risk reported drinking less over a 30-day period. This suggests that awareness of one's genetic makeup can lead to healthier drinking habits. This information could be particularly beneficial for those who experience alcohol flushing, a common reaction linked to these genetic variations. ^{3 5 6 7 8}

Who Is on the Research Team?

Kevin Chang, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is open to adults over the age of 18 who are native English speakers. There are no specific exclusion criteria, so it's quite inclusive for those interested in learning about alcohol flushing and its health risks.

Inclusion Criteria

Native English speaker

I am over 18 years old.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Awareness

Participants receive education on alcohol flushing and its health risks, and some are informed of their genotype results

3 months

Baseline, 1 month, 3 month

Follow-up

Participants are monitored for changes in alcohol consumption behavior and awareness of alcohol flushing

3 months

1 month, 3 month

What Are the Treatments Tested in This Trial?

Interventions

• ALDH2 Genotyping

Trial Overview The study focuses on whether educating people about the dangers of alcohol flushing and providing them with their personal ALDH2 genotype information can influence their drinking habits.

How Is the Trial Designed?

Group I: Genotype Revealed Experimental Treatment 1 Intervention

Subjects with ALDH2 mutation will be notified of positive genotype results after testing completed.

Group II: Gentoype Not-Revealed Placebo Group 1 Intervention

Subjects with ALDH2 mutation will not be notified of positive genotype results until after study completed.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Stanford Center for Asian Health Research and Education

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9235878/

ALDH2 variance in disease and populations - PMC Carriers of the ALDH2*2 allele were associated with reduced alcohol consumption and overall alcohol-related cancers. However, among the group of ...

2. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03422-y

Effectiveness of genetic feedback on alcohol metabolism to ... The results showed that participants with low ALDH2 activity (ALDH2*1/*2 genotypes) significantly reduced the frequency and amount of alcohol ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2977977/

Evaluation of a Brief Web-Based Genetic Feedback ... Participants with the ALDH2*1/*2 genotype who received personalized genetic feedback and risk information reported significant reductions in 30-day drinking ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517810300043X

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 ...

5. aacrjournals.org aacrjournals.org/cebp/article/34/5/744/762037/ALDH2-Deficiency-and-Alcohol-Intake-in-the-United

ALDH2 Deficiency and Alcohol Intake in the United States Participants with ALDH2*2/*2 showed the lowest levels of alcohol consumption, followed by those with ALDH2*1/*2, compared with those with ALDH2*1/*1. Among ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5447097/

Alcohol Consumption, Aldehyde Dehydrogenase 2 Gene ... Mendelian randomization (MR) studies have demonstrated that alcohol consumption predicted by ALDH2 genotype is causally related to cardiovascular risks.

7. med.stanford.edu med.stanford.edu/news/all-news/2019/12/alcohol-asian-glow-mutation-may-contribute-to-alzheimers.html

Alcohol, 'Asian glow' mutation may contribute to Alzheimer's ... This mutation in aldehyde dehydrogenase 2, or ALDH2, is associated with facial redness following alcohol consumption. It causes the activity of ...

8. withpower.com withpower.com/trial/phase-flushing-3-2024-2bf4a

Genetic Testing for Alcohol Flushing (AIAC Trial) The research articles do not provide specific safety data for genetic testing related to alcohol flushing, but they focus on the accuracy of predicting alcohol ...