NCT07032545

Brief Summary

Obesity can pose significant challenges to maintaining long-term health in cancer survivors by increasing their risk of cancer coming back. Eating a healthy diet is an important way to help manage weight and improve overall health. Broccoli microgreens (BMG) are young broccoli plants packed with nutrients, and research suggests they may help prevent cancer. Previous studies in mice showed that BMG can improve gut health and metabolism, leading to better health outcomes in obese animals. This study will test whether BMG can be a useful addition to the diet of obese breast cancer (BC) survivors who have a higher risk of their cancer returning. 24 obese BC survivors will be invited to eat one serving (one cup, \~57 gram) of fresh BMG every day for two weeks. This will help understand if people can stick to this diet, how their bodies respond, and whether it affects metabolism and inflammation-two key factors linked to cancer risk. Biological markers such as body fat, glucose and lipids as well as gut bacterial changes will be analyzed to see how BMG affects individual health. This study may help create new diet strategies to improve health, reduce cancer risk, and support long-term recovery in cancer patients who are overweight or obese. In the future, this research could help doctors personalize nutrition plans to better support cancer survivors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

June 10, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

June 10, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

breast cancerbroccoli microgreenobesitysurvivorshipgut microbiomemetabolomicsmetabotyping

Outcome Measures

Primary Outcomes (2)

  • Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study

    Feasibility will be assessed by calculating the percentage of participants who enrolled and completed the study by providing evaluable data at baseline, during the BMG intervention and after 2-weeks treatment.

    14 days

  • Compliance, as Assessed by the Percentage of the Participants Who Adhere to the Assigned BMG Intervention

    Compliance will be assessed by measuring the percent of the participants who consume the assigned BMG through the recommended cooking method during the 2-weeks of intervention period.

    14 days

Secondary Outcomes (4)

  • Body Composition, as Assessed by the Percentage of the Body Fat

    14 days

  • Blood Glucose, as Assessed by Fasting Blood Glucose Level

    14 days

  • Blood Lipids, as Assessed by Blood Lipid Concentrations

    14 days

  • The Gut microbiome, as Assessed by the Bacterial Composition Changes

    14 days

Study Arms (1)

BMG

EXPERIMENTAL

All participants are in BMG group and will consume one serving size (one cup, \~57 gram) of raw BMG daily for 2-week period of time.

Other: Broccoli microgreen (BMG)

Interventions

All participants will consume one serving size (one cup, \~57 gram) of raw BMG daily for 2-week period of time.

BMG

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Had a diagnosis of breast cancer (Stage I-III)
  • to 60 months post-curative treatment (surgery, chemotherapy, and/or radiation)
  • BMI \> 30 kg/m² (obese classification)
  • Willing to avoid cruciferous vegetables during the study
  • Able to sign an IRB-approved consent form

You may not qualify if:

  • Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., GI conditions, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder).
  • Allergy or intolerance to cruciferous vegetables
  • Currently taking broccoli extract supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast Evaluation and Treatment Program, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (3)

  • Bankole T, Ma T, Arora I, Lei Z, Raju M, Li Z, Li Y. The Effect of Broccoli Glucoraphanin Supplementation on Ameliorating High-Fat-Diet-Induced Obesity through the Gut Microbiome and Metabolome Interface. Mol Nutr Food Res. 2024 May;68(9):e2300856. doi: 10.1002/mnfr.202300856. Epub 2024 Apr 27.

    PMID: 38676466BACKGROUND
  • Turner ER, Luo Y, Buchanan RL. Microgreen nutrition, food safety, and shelf life: A review. J Food Sci. 2020 Apr;85(4):870-882. doi: 10.1111/1750-3841.15049. Epub 2020 Mar 6.

    PMID: 32144769BACKGROUND
  • Wojdylo A, Nowicka P, Tkacz K, Turkiewicz IP. Sprouts vs. Microgreens as Novel Functional Foods: Variation of Nutritional and Phytochemical Profiles and Their In Vitro Bioactive Properties. Molecules. 2020 Oct 12;25(20):4648. doi: 10.3390/molecules25204648.

    PMID: 33053861BACKGROUND

MeSH Terms

Conditions

ObesityOverweightBreast Neoplasms

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yuanyuan (Rose) Li, M.D., Ph.D.

    University of Maryland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuanyuan (Rose) Li, M.D., Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This is a single arm pilot intervention trial and all participants will be asked to consume allocated broccoli microgreen for 2 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 24, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations