Alcohol DrinkingABC-MetNCT07779967
Alcohol, Breast Cancer, and Metabolism
A study testing Low-alcohol level exposure and Breast-pumping time in people with Alcohol Drinking and Ethanol Intoxication, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Ethanol Intoxication, Breastfeeding
- What is being tested?
- Low-alcohol level exposure and Breast-pumping time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to 1 Mar 2032
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All aims
- -Drink alcohol (at least one alcoholic drink during lactation of a lactating female)
- For aims 1 and 2
- Nursing a 2- to 5-month-old infant
- Experienced with a breast pump
Who cannot join
- Pregnant
- Lifetime history of alcohol dependence
- Drink more than 3 standard drinks per day or more than 7 standard drinks per week in the month previous to enrollment
- Current regular use of drugs with addiction potential (other than alcohol)
- Use of medications known to interact with alcohol metabolism
- Current smoking
Show all 9Show fewer
- Anemia
- Diabetes
- Liver disease
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, 1 recruiting
- Recruiting
Bevier Hall; University of Illinois at Urbana Champaign
Urbana, Illinois, 61801
Marta, 217-300-2374, ypepino@illinois.edu
Eva Hu, BS, 217-300-4709, swhu2@illinois.edu
About this study
Official title: Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk
Alcohol consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.
Read the detailed description
Alcohol consumption has been associated with an increased risk of female breast cancer, including at low levels of intake. The biological mechanisms underlying this association are not fully understood. One proposed pathway involves the metabolism of alcohol to alcohol-related compounds that may affect tissue biology.
This study will examine alcohol metabolism in lactating women using paired blood and breast milk samples collected after low-level alcohol exposure. Human milk provides a non-invasive way to study biological processes occurring in the breast during lactation. By comparing alcohol-related measurements in milk and blood, and by considering the timing of sample collection relative to alcohol intake and breast pumping, the study will evaluate whether breast milk measurements provide information about local alcohol metabolism in the mammary gland that may not be reflected by blood measurements alone.
The goal of this research is to improve understanding of how low-level alcohol exposure may influence biological pathways relevant to breast cancer risk. Findings from this study may help inform future research and support clearer risk communication regarding alcohol consumption and breast health.
- Conditions
- Alcohol Drinking, Ethanol Intoxication, Breastfeeding
- Being tested
- Low-alcohol level exposure, Breast-pumping time
- Keywords
- lactating, women, alcohol, ethanol, metabolism, breastmilk
- Medical subject headings
- Alcohol Drinking, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-alcohol level exposureOther
Participants will consume a protocol-specified low-level alcohol exposure under study conditions. The assigned dose and biospecimen collection procedures will vary by study group.
Breast-pumping timeOther
Breast pumping before or after drinking ~ 1 standard drink or placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: lactating women dose response | Experimental | Lactating women who will drink ~0, 1 or 2 standard drinks of alcohol Receives: Other: Low-alcohol level exposure |
| Arm 2: timing of pumping | Experimental | Lactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking Receives: Other: Breast-pumping time |
| Aim 3: non-lactating control women | Other | Non-lactating women of similar age, BMI, and alcohol consumption characteristics will drink a similar dose of alcohol as lactating women for the assessment of systemic alcohol-related measurements. This group will serve as a comparison group for interpreting alcohol-related measurements in lactating participants. Receives: Other: Low-alcohol level exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood alcohol concentrations
Alcohol concentrations in blood
Measured: 2- 3 weeks
Milk alcohol concentration
Concentration of alcohol in breast milk
Measured: 2- 3 weeks
Milk acetaldehyde
Concentration of acetaldehyde in human milk
Measured: 1-3 weeks
Blood acetaldehyde
Concentration of acetaldehyde in blood
Measured: 1- 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start3 Sep 2026 (estimated)
- Primary completion13 Jul 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Aim 1: lactating women will be assessed with two doses of alcohol ; Aim 2, lactating women will be assessed with one dose of alcohol with varying breast pumping times; Aim 3 non-lactating women will be assessed with one dose of alcohol with varying blood sample sites (arterialized vs vein).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta Y Pepino de Gruev, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779967
- Sponsor's protocol ID
- 26-0686
- Acronym
- ABC-Met
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * De-identified participant demographic and screening variables (e.g., age, BMI, lactation characteristics) * Alcohol dosing information based on measured fat-free mass * Time-resolved physiological and pharmacokinetic data (e.g., blood alcohol concentration, breath alcohol concentration, elimination rates, AUC) * Quantitative biochemical measurements of ethanol and acetaldehyde concentrations in paired human milk and blood samples obtained using headspace gas chromatography with flame ionization detection (HS-GC-FID) * Derived variables generated for statistical and pharmacokinetic analyses
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT07779967
- Acronym / sponsor ID
- ABC-Met / 26-0686
- Conditions
- Alcohol Drinking, Ethanol Intoxication, Breastfeeding
- Keywords
- lactating, women, alcohol, ethanol, metabolism, breastmilk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 13 Jul 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 21 Aug 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 consumption, even at low levels, has been associated with increased breast cancer risk, but the biological mechanisms underlying this relationship remain unclear. This study will examine whether breast tissue may locally metabolize alcohol by measuring alcohol-related compounds in paired blood and breast milk samples from lactating women. The findings may help clarify alcohol-related biological pathways relevant to breast cancer risk and improve risk communication.
Detailed description
Alcohol consumption has been associated with an increased risk of female breast cancer, including at low levels of intake. The biological mechanisms underlying this association are not fully understood. One proposed pathway involves the metabolism of alcohol to alcohol-related compounds that may affect tissue biology.
This study will examine alcohol metabolism in lactating women using paired blood and breast milk samples collected after low-level alcohol exposure. Human milk provides a non-invasive way to study biological processes occurring in the breast during lactation. By comparing alcohol-related measurements in milk and blood, and by considering the timing of sample collection relative to alcohol intake and breast pumping, the study will evaluate whether breast milk measurements provide information about local alcohol metabolism in the mammary gland that may not be reflected by blood measurements alone.
The goal of this research is to improve understanding of how low-level alcohol exposure may influence biological pathways relevant to breast cancer risk. Findings from this study may help inform future research and support clearer risk communication regarding alcohol consumption and breast health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Aim 1: lactating women will be assessed with two doses of alcohol ; Aim 2, lactating women will be assessed with one dose of alcohol with varying breast pumping times; Aim 3 non-lactating women will be assessed with one dose of alcohol with varying blood sample sites (arterialized vs vein).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: lactating women dose response | Experimental | Other: Low-alcohol level exposureLactating women who will drink ~0, 1 or 2 standard drinks of alcohol |
| Arm 2: timing of pumping | Experimental | Other: Breast-pumping timeLactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking |
| Aim 3: non-lactating control women | Other | Other: Low-alcohol level exposureNon-lactating women of similar age, BMI, and alcohol consumption characteristics will drink a similar dose of alcohol as lactating women for the assessment of systemic alcohol-related measurements. This group will serve as a comparison group for interpreting alcohol-related measurements in lactating participants. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All aims
- -Drink alcohol (at least one alcoholic drink during lactation of a lactating female)
- For aims 1 and 2
- Nursing a 2- to 5-month-old infant
- Experienced with a breast pump
Key exclusion criteria (9 listed)
- Pregnant
- Lifetime history of alcohol dependence
- Drink more than 3 standard drinks per day or more than 7 standard drinks per week in the month previous to enrollment
- Current regular use of drugs with addiction potential (other than alcohol)
- Use of medications known to interact with alcohol metabolism
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 |
|---|---|---|
| Low-alcohol level exposureParticipants will consume a protocol-specified low-level alcohol exposure under study conditions. The assigned dose and biospecimen collection procedures will vary by study group. | Other | Aim 3: non-lactating control women, Arm 1: lactating women dose response |
| Breast-pumping timeBreast pumping before or after drinking ~ 1 standard drink or placebo drink | Other | Arm 2: timing of pumping |
Primary outcome
Blood alcohol concentrations
Time frame: 2- 3 weeks
Alcohol concentrations in blood
Milk alcohol concentration
Time frame: 2- 3 weeks
Concentration of alcohol in breast milk
Milk acetaldehyde
Time frame: 1-3 weeks
Concentration of acetaldehyde in human milk
Blood acetaldehyde
Time frame: 1- 3 weeks
Concentration of acetaldehyde in blood
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 8 Sep 2026.
- Individual participant dataSharing planned: Yes. * De-identified participant demographic and screening variables (e.g., age, BMI, lactation characteristics) * Alcohol dosing information based on measured fat-free mass * Time-resolved physiological and pharmacokinetic data (e.g., blood alcohol concentration, breath alcohol concentration, elimination rates, AUC) * Quantitative biochemical measurements of ethanol and acetaldehyde concentrations in paired human milk and blood samples obtained using headspace gas chromatography with flame ionization detection (HS-GC-FID) * Derived variables generated for statistical and pharmacokinetic analyses
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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.
Marta Y Pepino de Gruev principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-alcohol level exposure and Breast-pumping time in people with Alcohol Drinking and Ethanol Intoxication, run by University of Illinois at Urbana-Champaign 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 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 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 Marta Y Pepino de Gruev, Ph D (217-300-2374, ypepino@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood alcohol concentrations (time frame: 2- 3 weeks). 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 8 Sep 2026.