An interventional study of Low-alcohol level exposure and Breast-pumping time in Alcohol Drinking, Ethanol Intoxication and Breastfeeding, sponsored by University of Illinois at Urbana-Champaign. Recruiting at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.
Compared within Breast Feeding, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All aims
-Drink alcohol (at least one alcoholic drink during lactation of a lactating female)
For aims 1 and 2
Exclusion Criteria:
Lactating women who will drink \~0, 1 or 2 standard drinks of alcohol
Other: Low-alcohol level exposure
Lactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking
Other: Breast-pumping time
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.
Other: Low-alcohol level exposure
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 before or after drinking \~ 1 standard drink or placebo drink
Blood alcohol concentrations
Alcohol concentrations in blood
Time frame: 2- 3 weeks
Milk alcohol concentration
Concentration of alcohol in breast milk
Time frame: 2- 3 weeks
Milk acetaldehyde
Concentration of acetaldehyde in human milk
Time frame: 1-3 weeks
Blood acetaldehyde
Concentration of acetaldehyde in blood
Time frame: 1- 3 weeks
Plan to share: 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
Supporting information: Study protocol, Informed consent form
Time frame: From the end of the grant until NIAAA Da allows it.
Access criteria: The data will be shared with NIAAA DA and they will determine the protocol to access.
Data sharing details ↗ · www.niaaa.nih.gov
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jul 2031, 58 months later.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 58 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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University of Illinois at Urbana-Champaign →