Obesity and OverweightNCT07032545
Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors
A study testing Broccoli microgreen (BMG) in people with Obesity and Overweight and Breast Cancer Survivorship, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity and Overweight, Breast Cancer Survivorship
- What is being tested?
- Broccoli microgreen (BMG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Breast Evaluation and Treatment Program, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Katherine Tkaczuk, 410-328-7394, ktkaczuk@umm.edu
About this study
Official title: Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors
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.
Read more
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.
Read the detailed description
In this pilot clinical trial, 24 obese BC survivors from the University of Maryland Medical Center in Baltimore will be recruited to participate in a single-arm 2-week BMG (broccoli microgreen) intervention trial. Several outcomes will be tested, including study feasibility, patient compliance of one serving size of raw BMG and metabolic parameter changes. Biological samples such as blood and fecal samples as well as study questionnaires will be collected at baseline and 2 weeks post-intervention to measure the outcomes. The main hypothesis of this study is that incorporating the proposed BMG quantity into daily meals is feasible in obese BC survivors. The secondary hypothesis is that BMG may improve the metabolic profiles and gut health in obese subjects. This proof-of-concept prospective study will provide important clinical insights into beneficial effects of BMG on mitigating obesity and related metabolic disorders, which strategies may complement traditional survivorship management and support long-term health outcomes for BC survivors.
- Conditions
- Obesity and Overweight, Breast Cancer Survivorship
- Being tested
- Broccoli microgreen (BMG)
- Keywords
- breast cancer, broccoli microgreen, obesity, survivorship, gut microbiome, metabolomics, metabotyping
- Medical subject headings
- Obesity, Overweight, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli microgreen (BMG)Other
All participants will consume one serving size (one cup, ~57 gram) of raw BMG daily for 2-week period of time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Broccoli microgreen (BMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Secondary outcomes (4)
Body Composition, as Assessed by the Percentage of the Body Fat
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.
Measured: 14 days
Blood Glucose, as Assessed by Fasting Blood Glucose Level
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.
Measured: 14 days
Blood Lipids, as Assessed by Blood Lipid Concentrations
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.
Measured: 14 days
The Gut microbiome, as Assessed by the Bacterial Composition Changes
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start3 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm pilot intervention trial and all participants will be asked to consume allocated broccoli microgreen for 2 weeks.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park
- Responsible party
- Principal investigator, Yuanyuan (Rose) Li, University of Maryland, Baltimore
- Investigators
- Yuanyuan (Rose) Li, M.D., Ph.D., Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032545
- Sponsor's protocol ID
- HP-00113949
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38676466Turner 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.
PubMed 32144769Wojdylo 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.
PubMed 33053861
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07032545
- Acronym / sponsor ID
- HP-00113949
- Conditions
- Obesity and Overweight, Breast Cancer Survivorship
- Keywords
- breast cancer, broccoli microgreen, obesity, survivorship, gut microbiome, metabolomics, metabotyping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland, College Park
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this pilot clinical trial, 24 obese BC survivors from the University of Maryland Medical Center in Baltimore will be recruited to participate in a single-arm 2-week BMG (broccoli microgreen) intervention trial. Several outcomes will be tested, including study feasibility, patient compliance of one serving size of raw BMG and metabolic parameter changes. Biological samples such as blood and fecal samples as well as study questionnaires will be collected at baseline and 2 weeks post-intervention to measure the outcomes. The main hypothesis of this study is that incorporating the proposed BMG quantity into daily meals is feasible in obese BC survivors. The secondary hypothesis is that BMG may improve the metabolic profiles and gut health in obese subjects. This proof-of-concept prospective study will provide important clinical insights into beneficial effects of BMG on mitigating obesity and related metabolic disorders, which strategies may complement traditional survivorship management and support long-term health outcomes for BC survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm pilot intervention trial and all participants will be asked to consume allocated broccoli microgreen for 2 weeks.
| Arm | Type | Receives |
|---|---|---|
| BMG | Experimental | Other: Broccoli microgreen (BMG)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli microgreen (BMG)All participants will consume one serving size (one cup, ~57 gram) of raw BMG daily for 2-week period of time. | Other | BMG |
Primary outcome
Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study
Time frame: 14 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 Intervention
Time frame: 14 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.
4 secondary outcomes
Body Composition, as Assessed by the Percentage of the Body Fat
Time frame: 14 days
Blood Glucose, as Assessed by Fasting Blood Glucose Level
Time frame: 14 days
Blood Lipids, as Assessed by Blood Lipid Concentrations
Time frame: 14 days
The Gut microbiome, as Assessed by the Bacterial Composition Changes
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 38676466Bankole 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.
- Background: PubMed 32144769Turner 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.
- Background: PubMed 33053861Wojdylo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanyuan (Rose) Li, M.D., Ph.D. principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli microgreen (BMG) in people with Obesity and Overweight and Breast Cancer Survivorship, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan (Rose) Li, M.D., Ph.D. (13014050776, roseli15@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07032545, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.