Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Broccoli microgreen (BMG) (Other)
结局指标
主要结局
Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study
时间窗: 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
时间窗: 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.
次要结局
- Body Composition, as Assessed by the Percentage of the Body Fat(14 days)
- Blood Glucose, as Assessed by Fasting Blood Glucose Level(14 days)
- Blood Lipids, as Assessed by Blood Lipid Concentrations(14 days)
- The Gut microbiome, as Assessed by the Bacterial Composition Changes(14 days)
研究者
Yuanyuan (Rose) Li
Assistant Professor
University of Maryland, Baltimore