[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07032545":3,"trial-entities:NCT07032545":120,"trial-summary:NCT07032545":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":42,"secondary_outcomes":50,"sex":63,"minimum_age":64,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":79,"locations":83,"central_contacts":99,"overall_officials":104,"references":108,"see_also_links":119},"NCT07032545","HP-00113949","Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors","Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors","RECRUITING","2028-12-31","2025-12","2025-12-23","2025-12-03","University of Maryland, Baltimore","OTHER",true,"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.\n\nPrevious 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.\n\n24 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.\n\nThis 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.","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.",[19,20],"Obesity and Overweight","Breast Cancer Survivorship",[22,23,24,25,26,27,28],"breast cancer","broccoli microgreen","obesity","survivorship","gut microbiome","metabolomics","metabotyping","INTERVENTIONAL","SUPPORTIVE_CARE",[32],"NA",{"count":34,"type":35},24,"ESTIMATED",[37],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Broccoli microgreen (BMG)","All participants will consume one serving size (one cup, \\~57 gram) of raw BMG daily for 2-week period of time.",[41],"BMG",[43,47],{"measure":44,"description":45,"timeFrame":46},"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",{"measure":48,"description":49,"timeFrame":46},"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.",[51,54,57,60],{"measure":52,"description":53,"timeFrame":46},"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 \\\u003C 0.05, and results will be based on two-tailed statistical tests.",{"measure":55,"description":56,"timeFrame":46},"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 \\\u003C 0.05, and results will be based on two-tailed statistical tests.",{"measure":58,"description":59,"timeFrame":46},"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 \\\u003C 0.05, and results will be based on two-tailed statistical tests.",{"measure":61,"description":62,"timeFrame":46},"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.","FEMALE",null,false,{"inclusion":67,"exclusion":74,"raw_text":78},[68,69,70,71,72,73],"Female","Had a diagnosis of breast cancer (Stage I-III)","2 to 60 months post-curative treatment (surgery, chemotherapy, and\u002For radiation)","BMI \\> 30 kg\u002Fm² (obese classification)","Willing to avoid cruciferous vegetables during the study","Able to sign an IRB-approved consent form",[75,76,77],"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","Inclusion Criteria:\n\n* Female\n* Had a diagnosis of breast cancer (Stage I-III)\n* 2 to 60 months post-curative treatment (surgery, chemotherapy, and\u002For radiation)\n* BMI \\> 30 kg\u002Fm² (obese classification)\n* Willing to avoid cruciferous vegetables during the study\n* Able to sign an IRB-approved consent form\n\nExclusion Criteria:\n\n* 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).\n* Allergy or intolerance to cruciferous vegetables\n* Currently taking broccoli extract supplements",[80,81,82],"CHILD","ADULT","OLDER_ADULT",[84],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"Breast Evaluation and Treatment Program, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Katherine Tkaczuk","CONTACT","410-328-7394","ktkaczuk@umm.edu",{"lat":97,"lon":98},39.29038,-76.61219,[100],{"name":101,"role":93,"phone":102,"email":103},"Yuanyuan (Rose) Li, M.D., Ph.D.","13014050776","roseli15@umd.edu",[105],{"name":101,"affiliation":106,"role":107},"University of Maryland","PRINCIPAL_INVESTIGATOR",[109,113,116],{"pmid":110,"type":111,"citation":112},"38676466","BACKGROUND","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\u002Fmnfr.202300856. Epub 2024 Apr 27.",{"pmid":114,"type":111,"citation":115},"32144769","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\u002F1750-3841.15049. Epub 2020 Mar 6.",{"pmid":117,"type":111,"citation":118},"33053861","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\u002Fmolecules25204648.",[],{"nct_id":4,"conditions":121,"biomarkers":124},[122,123],"Breast Carcinoma","Obesity",[],{"nct_id":4,"found":15,"summary":126,"prompt_version":64},{"design":127,"status":128,"heading":129,"summary":130,"follow_up":131,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"This is a single-arm study, meaning all 24 participants will receive the same intervention. It is a pilot study, which means it's an early look at the intervention.","completed","Broccoli Microgreens for Obese Breast Cancer Survivors","This study is looking at whether eating broccoli microgreens (BMG) can be a helpful part of the diet for obese breast cancer survivors. Obesity can increase the risk of cancer returning, and BMG are young broccoli plants packed with nutrients that may help. Researchers will ask 24 obese women who have survived breast cancer to eat one cup (about 57 grams) of raw BMG every day for two weeks. The main goals are to see if it's practical for people to stick to this diet and if they actually do it. This study is currently unclear about its recruitment status.","Participants will be followed for 14 days, which is the duration of the intervention and when the primary endpoints are measured.",100,"You would eat one cup of raw broccoli microgreens daily for two weeks. Biological samples like blood and stool, along with questionnaires, will be collected at the beginning and end of the two weeks.","Not stated in the trial record.",[]]