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Broccoli Microgreen Metabotyping in Obese Breast Cancer Survivors

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Study AimThis study examines the feasibility and compliance of consuming broccoli microgreens in obese breast cancer survivor women, with the goal of assessing its impact on their health over a two-week period.
What is being tested

Broccoli microgreen (BMG)

Other
Who is being recruted

Obesity and Overweight

+ Breast Cancer Survivorship
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorUniversity of Maryland, Baltimore
Study ContactYuanyuan (Rose) Li, M.D., Ph.D.
Last updated: October 6, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

This clinical trial is focused on exploring the potential health benefits of broccoli microgreens for obese breast cancer survivors. The study involves participants from the University of Maryland Medical Center in Baltimore who will incorporate a specific serving of raw broccoli microgreens into their daily meals for two weeks. The researchers aim to determine if this addition is practical for the participants and whether it can positively affect their metabolism and gut health. The insights gained from this study could lead to new strategies to improve the management of obesity and metabolic disorders in breast cancer survivors, complementing traditional care and supporting long-term health. Participants in the study will consume broccoli microgreens as part of their regular diet and undergo assessments to track changes in their metabolic parameters and gut health. To measure the effects, the study will collect biological samples such as blood and fecal samples, and participants will also complete questionnaires at the beginning and end of the two-week period. This information will help evaluate the feasibility of the intervention and any potential health benefits, providing valuable data on how broccoli microgreens might assist in managing obesity-related issues for breast cancer survivors.

Official TitleMetabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors 
Principal SponsorUniversity of Maryland, Baltimore
Study ContactYuanyuan (Rose) Li, M.D., Ph.D.
Last updated: October 6, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Obesity and Overweight
Breast Cancer Survivorship
Criteria
6 inclusion criteria required to participate
Female
Had a diagnosis of breast cancer (Stage I-III)
2 to 60 months post-curative treatment (surgery, chemotherapy, and/or radiation)
BMI > 30 kg/m² (obese classification)

Show More Criteria

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

Body fat composition will be determined by measuring the percentage of body fat by a Handheld Body Composition Monitor. Data will be analyzed by comparing the mean change before and after the BMG dietary treatment using paired samples t-tests. Statistical significance will be assumed at p \< 0.05, and results will be based on two-tailed statistical tests.

The fasting blood glucose level will be measured to determine the glucose concentration changes before and after the BMG dietary treatment. Data will be analyzed by comparing the mean change of the fasting glucose concentrations before and after the BMG dietary treatment using paired samples t-tests. Statistical significance will be assumed at p \< 0.05, and results will be based on two-tailed statistical tests.

The blood lipids including total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides will be measured to determine the lipid concentration changes before and after the BMG dietary treatment. Data will be analyzed by comparing the mean change of the individual lipid concentrations before and after the intervention using paired samples t-tests. Statistical significance will be assumed at p \< 0.05, and results will be based on two-tailed statistical tests.

Gut microbial composition changes will be evaluated by sequencing-based methods before and after the BMG diet intervention. Key parameters for assessing microbiome changes include alpha and beta diversity changes as well as the individual bacterial composition differences in response to BMG intervention.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of MarylandBaltimore, United StatesSee the location
Recruiting soonOne Study Center