Cross-Over Broccoli Sprouts Trial - Qidong
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Urinary levels of glucoraphanin or sulforaphane and metabolites.
研究概览
简要总结
The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 25-65 in good general health with no history of a chronic illness
- •normal liver function tests (ALT, AST, bilirubin)
- •normal renal function tests (creatinine, BUN, urinalysis)
- •serum alpha-fetoprotein negative
排除标准
- •personal history of cancer, except for non-melanoma skin cancer
- •use of prescribed medications
- •hepatomegaly by clinical exam
- •unwillingness to avoid cruciferous vegetable consumption for the duration of the study
- •for women, a positive pregnancy test.
研究组 & 干预措施
glucoraphanin-rich broccoli extract
干预措施: broccoli sprouts extract (Dietary Supplement)
sulforaphane-rich broccoli extract
干预措施: broccoli sprouts extract (Dietary Supplement)
结局指标
主要结局
Urinary levels of glucoraphanin or sulforaphane and metabolites.
时间窗: Endpoints will be assessed on urine samples collected daily during the intervention.
次要结局
- Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants(Endpoints will be assessed on urine samples collected daily during the intervention.)
研究者
Thomas Kensler
Professor
Johns Hopkins Bloomberg School of Public Health