Celery-Based Dietary Intervention: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Apigenin levels in blood and urine
研究概览
简要总结
This pilot clinical trial studies the side effects and best dose of apigenin in increasing health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound that may have anti-cancer activities. Eating a celery-based diet may help in prevention and treatment of inflammatory diseases including cancer.
详细描述
PRIMARY OBJECTIVES; I. To determine the feasibility of apigenin oral supplementation using a specially formulated celery-banana bread.
II. To determine the safety and tolerability of apigenin supplementation.
OUTLINE: This is a dose-escalation study.
Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be followed in Stefanie Spielman Comprehensive Breast Center (SSCBC) High Risk Breast Clinic
- •No known allergy to ingredients of banana bread preparation (eggs, almonds and other nuts since the celery also has almond powder)
- •Must be > 1 year from pregnancy, lactation or chemotherapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Ability to give informed consent
- •Participate in the specified study visits and laboratory testing including three (20 mL) blood draws and three 24 hour urine collections
排除标准
- •Concurrent malignancy or metastatic malignancy of any kind
- •Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
- •Current and past history of hypertension
- •Chronic use of any herbal or dietary supplement containing apigenin within the 3 months prior to entry on the study
- •Pregnant or nursing women
- •Concurrent use of tamoxifen, raloxifene, or any of the aromatase inhibitors
结局指标
主要结局
Apigenin levels in blood and urine
时间窗: Up to 14 days
Paired t-tests will be used to compare mean apigenin levels.
次要结局
未报告次要终点
研究者
Sagar Sardesai
Principal Investigator
Ohio State University Comprehensive Cancer Center