Broccoli Sprout Intervention in Qidong, P.R. China
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
研究概览
简要总结
This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 21-65 years
- •in good general health with no history of chronic illness
- •normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)
- •normal renal function tests (creatinine, blood urea nitrogen, 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
- •for women, a positive pregnancy test
研究组 & 干预措施
Broccoli Sprout Extract Beverage
干预措施: Broccoli Sprout Extract Beverage (Drug)
Placebo beverage
干预措施: placebo beverage (Drug)
结局指标
主要结局
Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
时间窗: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.
Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
次要结局
- Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)(Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12]))