Breast Cancer Survivorship, Obesity and Overweight
Conditions
Keywords
breast cancer, broccoli microgreen, obesity, survivorship, gut microbiome, metabolomics, metabotyping
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.
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.
Interventions
OTHERBroccoli microgreen (BMG)
All participants will consume one serving size (one cup, \ 57 gram) of raw BMG daily for 2-week period of time.
Sponsors
University of Maryland, College Park
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single arm pilot intervention trial and all participants will be asked to consume allocated broccoli microgreen for 2 weeks.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition, as Assessed by the Percentage of the Body Fat | 14 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 Level | 14 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 Concentrations | 14 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 Changes | 14 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. |
Countries
United States
Contacts
Primary ContactYuanyuan (Rose) Li, M.D., Ph.D.
Outcome results
None listed