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

NCT04374747 | Unknown

• 2 other identifiers: 2019-53821R01CA230478-01A1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female; Inflammation; Postpartum Weight Retention; Diet, Healthy; Risk Reduction

Outcome Measures

Primary Outcomes (6)

• DNA methylation

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

  20 weeks

• Inflammatory markers in milk

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

  20 weeks

• Early weight

  maternal weight

  20 weeks

• Early waist circumference

  maternal waist circumference

  20 weeks

• One-year Weight

  maternal weight

  One-year

• One-year Waist Circumference

  maternal weight circumference

  one year

Other Outcomes (1)

• Fruit and Vegetable Intake

  one year

Study Arms (2)

Dietary Intervention

EXPERIMENTAL

Intensive dietary counseling and fruit and vegetable box delivery.

Behavioral: Dietary Counseling

Information

NO INTERVENTION

Control condition of information on healthy eating during breastfeeding

Interventions

Dietary Counseling BEHAVIORAL

The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .

Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

RECRUITING

Related Publications (2)

• Essa AR, Browne EP, Punska EC, Perkins K, Boudreau E, Wiggins H, Anderton DL, Sibeko L, Sturgeon SR, Arcaro KF. Dietary Intervention to Increase Fruit and Vegetable Consumption in Breastfeeding Women: A Pilot Randomized Trial Measuring Inflammatory Markers in Breast Milk. J Acad Nutr Diet. 2018 Dec;118(12):2287-2295. doi: 10.1016/j.jand.2018.06.015. Epub 2018 Sep 10.

  PMID: 30213617 BACKGROUND

• Sturgeon SR, Sibeko L, Balasubramanian R, Arcaro KF. New Moms Wellness Study: the randomized controlled trial study protocol for an intervention study to increase fruit and vegetable intake and lower breast cancer risk through weekly counseling and supplemental fruit and vegetable box delivery in breastfeeding women. BMC Womens Health. 2022 Sep 24;22(1):389. doi: 10.1186/s12905-022-01967-9.

  PMID: 36153518 DERIVED

MeSH Terms

Conditions

Inflammation; Gestational Weight Gain; Risk Reduction Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Kathleen Arcaro, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

• Lindiwe Sibeko, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

• Susan Sturgeon, DrPH

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Arcaro, PhD

CONTACT

413-577-1823; karcaro@umass.edu

Susan Sturgeon, DrPH

CONTACT

413-577-1364; ssturgeon@schoolph.umass.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Key laboratory analyses will conducted by laboratories blinded to intervention arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: October 24, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)