A Pilot Study Evaluating the Bioavailability and Mucosal Bioactivity of the Dietary Supplement, Avmacol®, in Healthy Volunteers With Optimization of Buccal Cell Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Number of buccal (cheek) cells collected by participants versus a trained professional
研究概览
简要总结
Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to evaluate both bioavailability and its bioactivity in cheek cells.
详细描述
Avmacol is an over-the counter dietary supplement containing broccoli seed and sprout extracts in tablet form. Natural plant substances within Avmacol, called phytochemicals, are hypothesized to stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke. The purpose of this study is twofold: 1) to assess the protective effects of Avmacol on the mucosa (cheek cells) of healthy volunteers, and 2) to assess the collection of cheek cells by scraping, as a less invasive method of studying drug effects in the body compared to drawing blood or a tissue biopsy. Ultimately, these results will be used to design a larger study of Avmacol in patients with tobacco-related head and neck cancer. Avmacol will be studied as a way to possibly prevent a second cancer from developing in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Age ≥ 18 years.
- •Members of all racial and ethnic groups are eligible.
- •Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration.
- •No chronic use of steroids
- •Karnofsky Performance Scale ≥90%
- •Able to provide written, informed consent
- •For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
- •Willing to avoid cruciferous vegetables during the study interventions
- •Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
- •Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
- •Willing and able to perform self-collection of buccal cells as stated in the instruction manual
排除标准
- •No current or former diagnosis of cancer, with the exception of: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection
- •No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
- •Chronic use anticoagulation
结局指标
主要结局
Number of buccal (cheek) cells collected by participants versus a trained professional
时间窗: 5 days
Number of buccal cells collected by cytobrush during week 1 (days 1-5) of the study
次要结局
- Induction of NRF2 pathway transcripts in buccal cells by Avmacol(5 days)
研究者
Julie E. Bauman, MD, MPH
MD, MPH
University of Pittsburgh