Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

Research Group
Nutritional Science
University of Massachusetts, Amherst
Recruiting ID
For more information, see NCT04374747
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.
Dietary Counseling
Breast Cancer Female, Inflammation, Postpartum Weight Retention, Diet, Healthy, Risk Reduction
Kathleen Arcaro, PhD, Lindiwe Sibeko, PhD, Susan Sturgeon, DrPH

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