Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT07032545

Not Yet Recruiting

Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors

Interventional

Phase not listed

University of Maryland

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.

Show Detailed Description

Treatment Category

Other

Required Mutations

None

Trial Started

2025-11-01

Last Updated by Sponsor

2025-10-06

Estimated Completion

2027-08-31

Eligibility

Inclusion Criteria

* 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)

* Willing to avoid cruciferous vegetables during the study

* Able to sign an IRB-approved consent form

Exclusion Criteria

* 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

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll24

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

Broccoli microgreen (BMG)

Outcome Measures

Primary Outcome Measures

Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study14 days

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, as Assessed by the Percentage of the Participants Who Adhere to the Assigned BMG Intervention14 days

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 Outcome Measures

Body Composition, as Assessed by the Percentage of the Body Fat14 days

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.

Blood Glucose, as Assessed by Fasting Blood Glucose Level14 days

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.

Blood Lipids, as Assessed by Blood Lipid Concentrations14 days

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.

The Gut microbiome, as Assessed by the Bacterial Composition Changes14 days

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.