Localized Mammary Alcohol Metabolism as a Mechanism Linking Low-Level Alcohol Intake to Breast Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood alcohol concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Liver disease
研究组 & 干预措施
Arm 2: timing of pumping
Lactating women will pump at two different times from alcohol drinking and at one of these times after placebo drinking
干预措施: Breast-pumping time (Other)
Arm 1: lactating women dose response
Lactating women who will drink ~0, 1 or 2 standard drinks of alcohol
干预措施: Low-alcohol level exposure (Other)
Aim 3: non-lactating control women
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.
干预措施: Low-alcohol level exposure (Other)
结局指标
主要结局
Blood alcohol concentrations
时间窗: 2- 3 weeks
Alcohol concentrations in blood
Milk alcohol concentration
时间窗: 2- 3 weeks
Concentration of alcohol in breast milk
Milk acetaldehyde
时间窗: 1-3 weeks
Concentration of acetaldehyde in human milk
Blood acetaldehyde
时间窗: 1- 3 weeks
Concentration of acetaldehyde in blood
次要结局
未报告次要终点
