Metabotyping of Broccoli Microgreen in Obese Breast Cancer Survivors

Official title

Metabotyping of a Functional Food, Broccoli Microgreen, in Obese Breast Cancer Survivors

Overview

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

• Other Broccoli microgreen (BMG)
  All participants will consume one serving size (one cup, \~57 gram) of raw BMG daily for 2-week period of time.

Primary outcome measures

• Feasibility, as Assessed by the Percentage of Participants Who Enrolled and Completed the Study [Time frame: 14 days]
• Compliance, as Assessed by the Percentage of the Participants Who Adhere to the Assigned BMG Intervention [Time frame: 14 days]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Breast Evaluation and Treatment Program, University of Maryland Marlene and Stewart Greene — Baltimore

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. PMID 38676466
• 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: 10.1111/1750-3841.15049. Epub 2020 Mar 6. PMID 32144769
• 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/molecules25204648. PMID 33053861

Identifiers

NCT: NCT07032545 · HP-00113949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗