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临床试验/NCT04374747
NCT04374747Unknown不适用

Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年10月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
2
主要终点
DNA methylation

研究概览

简要总结

Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation/weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.

详细描述

Overview of home visits and activities completed by all participants

Visit 1 Introductory Visit (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 5 weeks postpartum

  • Informed Consent document administered.
  • Public Data Sharing Informed Consent document administered.
  • Three questionnaires: New Moms Health, Physical Activity, and Breastfeeding Practices
  • Maternal height, weight, and waist circumference measured.
  • Instructions provided for future collection of biospecimens.
  • Complete one 24-Hour Dietary Recall
  • Instructions provided for two additional 24-Hour Dietary Recalls.

Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum

  • Provide bilateral breast milk samples and completed questionnaire.
  • Provide infant stool sample and completed questionnaire.
  • Two questionnaires: Infant Feeding, and Medication & Supplement
  • Infant length and weight measured.
  • Maternal and infant skin carotenoids measured.
  • Nutrition education provided.
  • Optional collection of maternal stool sample and completed questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Key laboratory analyses will conducted by laboratories blinded to intervention arm.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Have given birth in past five weeks or are currently pregnant
  • Breastfeeding baby at entry into the study
  • Consuming five or fewer servings of fruits and vegetables daily at baseline
  • Live within 25 miles of Amherst MA

排除标准

  • Invasive breast cancer
  • Any cancer except non-melanoma skin cancer in past five years
  • History of Crohn's disease, celiac sprue, or other malabsorption syndrome, which may interfere with digesting or absorption of nutrients
  • A personal history of diabetes (excluding gestational diabetes)
  • Baseline BMI of <18.5
  • Dietary restrictions that prevent participant from eating 8 to 10 servings of fruits and vegetables

结局指标

主要结局

DNA methylation

时间窗: 20 weeks

% methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk

Early waist circumference

时间窗: 20 weeks

maternal waist circumference

One-year Waist Circumference

时间窗: one year

maternal weight circumference

One-year Weight

时间窗: One-year

maternal weight

Inflammatory markers in milk

时间窗: 20 weeks

Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D

Early weight

时间窗: 20 weeks

maternal weight

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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