Health TrialsbyHealthPanel

Alcohol, Breast Cancer, and Metabolism

ConditionsAlcohol DrinkingEthanol IntoxicationBreastfeeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorUniversity of Illinois at Urbana-Champaign

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nursing a 2- to 5-month-old infant

Experienced with a breast pump

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low-alcohol level exposure

    Other intervention

    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 time

    Other intervention

    Breast pumping before or after drinking \~ 1 standard drink or placebo drink

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Arm 1: lactating women dose responseExperimental treatment 1 intervention
Group B: Arm 2: timing of pumpingExperimental treatment 1 intervention
Group C: Aim 3: non-lactating control womenOther 1 intervention

Trial outcomes

Primary outcomes

1

Blood alcohol concentrations

Alcohol concentrations in blood

Time frame
2- 3 weeks
2

Milk alcohol concentration

Concentration of alcohol in breast milk

Time frame
2- 3 weeks
3

Milk acetaldehyde

Concentration of acetaldehyde in human milk

Time frame
1-3 weeks
4

Blood acetaldehyde

Concentration of acetaldehyde in blood

Time frame
1- 3 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Urbana-Champaign

Lead sponsor

Source ClinicalTrials.gov
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