Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum - Provide bilateral breast milk samples and completed questionnaire. - Provide infant stool sample and completed questionnaire. - Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement - Infant length and weight measured. - Maternal weight and waist circumference measured. - Maternal and infant skin carotenoids measured. Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum - Provide bilateral breast milk samples and completed questionnaire. - Provide infant stool sample and completed questionnaire. - Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement. - Infant length and weight measured. - Maternal weight and waist circumference measured. - Maternal and infant skin carotenoids measured. - Optional collection of maternal stool samples and completed questionnaire. Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum - Provide bilateral breast milk samples and completed questionnaire. - Provide infant stool sample and completed questionnaire. - Four questionnaires: Physical Activity, Infant Feeding, Medication and Supplement, and Breast Health - Infant length and weight measured. - Maternal weight and waist circumference measured. - Maternal and infant skin carotenoids measured. - Optional collection of maternal stool samples and completed questionnaire. Annual Follow-up Visit (Maximum of 2) (1 hour) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at one-year intervals after Visit 5 - Three questionnaires: Physical Activity, Breast Health, Young Child Feeding - Infant height and weight measured. - Maternal weight and waist circumference measured. - Maternal and infant skin carotenoids measured. Monthly Inquiry (1 - 2 minutes) Occurs monthly until no longer breastfeeding • Complete the Breast Feeding Update Questionnaire online via a survey sent through REDCap, or through a phone call. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04374747
Study type Interventional
Source University of Massachusetts, Amherst
Contact Kathleen Arcaro, PhD
Phone 413-577-1823
Email karcaro@umass.edu
Status Recruiting
Phase N/A
Start date October 24, 2019
Completion date April 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Active, not recruiting NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Active, not recruiting NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect