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Dietary Counseling for Reducing Breast Cancer Risk

Q: Is there still room for additional participants in this experiment?

<p>Affirmative, according to clinicaltrials.gov's information this trial is currently enlisting participants. This experiment was initially posted on October 24th 2019 and has been recently revised on November 3rd 2022; it requires 400 individuals from one medical facility to take part in the study.</p>

Q: What is the highest capacity of participants in this experiment?

<p>Affirmative. Clinicaltrials.gov has verifiable information that this clinical trial commenced on October 24th 2019, and is still accepting participants as of November 3rd 2022. 400 volunteers are sought after to participate at one venue.</p>

N/A

Waitlist Available

Led By Susan Sturgeon, DrPH

Research Sponsored by University of Massachusetts, Amherst

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial will assess whether or not increasing fruit and vegetable intake can reduce the risk of breast cancer by looking at changes in DNA methylation and cytokine profiles in breastmilk.

Who is the study for?

This trial is for breastfeeding women who have recently given birth or are pregnant, living near Amherst MA, and eat five or fewer servings of fruits and vegetables daily. Women with a history of invasive breast cancer, other recent cancers, malabsorption syndromes like Crohn's disease or celiac sprue, diabetes (except gestational), underweight BMI (<18.5), or dietary restrictions against high fruit/vegetable intake cannot join.Check my eligibility

What is being tested?

The study tests if eating 8-10 servings of colorful fruits and vegetables daily can reduce breast cancer risk markers in lactating women. Participants will be randomly placed into two groups: one receiving dietary counseling plus fruit/vegetable supplies for 20 weeks followed by just counseling; the other getting general diet advice for breastfeeding mothers.See study design

What are the potential side effects?

There are generally no severe side effects expected from increasing fruit and vegetable intake as part of a healthy diet. However, changes in diet may sometimes cause mild digestive adjustments such as bloating or changes in bowel habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DNA methylation

Early waist circumference

Early weight

+3 more

Other outcome measures

Fruit and Vegetable Intake

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dietary InterventionExperimental Treatment1 Intervention

Intensive dietary counseling and fruit and vegetable box delivery.

Group II: InformationActive Control1 Intervention

Control condition of information on healthy eating during breastfeeding

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary Counseling

2011

Completed Phase 3

~1860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,267 Total Patients Enrolled

13 Trials studying Inflammation

3,489 Patients Enrolled for Inflammation

University of Massachusetts, AmherstLead Sponsor

78 Previous Clinical Trials

467,372 Total Patients Enrolled

1 Trials studying Inflammation

40 Patients Enrolled for Inflammation

Susan Sturgeon, DrPHPrincipal InvestigatorUniversity of Massachusetts, Amherst

Media Library

Dietary Counseling 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374747 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still room for additional participants in this experiment?

"Affirmative, according to clinicaltrials.gov's information this trial is currently enlisting participants. This experiment was initially posted on October 24th 2019 and has been recently revised on November 3rd 2022; it requires 400 individuals from one medical facility to take part in the study."

Answered by AI

What is the highest capacity of participants in this experiment?

"Affirmative. Clinicaltrials.gov has verifiable information that this clinical trial commenced on October 24th 2019, and is still accepting participants as of November 3rd 2022. 400 volunteers are sought after to participate at one venue."

Answered by AI

Recent research and studies

Journal of the Academy of Nutrition and DieteticsJournal

Dietary Intervention to Increase Fruit and Vegetable Consumption in Breastfeeding Women: A Pilot Randomized Trial Measuring Inflammatory Markers in Breast Milk

Essa, Angela R., Eva P. Browne, Elizabeth C. Punska, Katelyn Perkins, Emily Boudreau, Hilary Wiggins, Douglas L. Anderton, Lindiwe Sibeko, Susan R. Sturgeon, and Kathleen F. Arcaro. 2018. “Dietary Intervention to Increase Fruit and Vegetable Consumption in Breastfeeding Women: A Pilot Randomized Trial Measuring Inflammatory Markers in Breast Milk”. Journal of the Academy of Nutrition and Dietetics. Elsevier BV. doi:10.1016/j.jand.2018.06.015.

clinicaltrials.govStudy

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

2019. "Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04374747.