In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- DHT Levels
研究概览
简要总结
The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.
The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40-75 years
- •Low or intermediate grade prostate cancer (as defined by Gleason sum less than or equal to 7) and clinical stage T1 or T2
- •Serum Prostate specific antigen less than 20 ng/ml
- •Have elected radical prostatectomy, Brachytherapy or active surveillance as their primary treatment
排除标准
- •No current physician diagnosed disease (including but not limited to): kidney disease requiring dialysis, cognitive deficits, substance abuse
- •BMI < 18.5 kg/m2 or > 40 kg/m2
- •Use of any hormonal treatments, including but not limited to testosterone
- •Any previous cancer diagnosis or treatment within the previous five years, excluding non-melanoma skin cancer
- •Inability or unwillingness to eat a diet that is free of Brassica vegetables for the duration of the study
- •Use of any dietary supplements other than a multivitamin (including herbal preparations)
- •Allergy to cruciferous vegetables or any of the specific fillers used in the placebo
- •Usual consumption of > 5 servings per week of Brassica vegetables
研究组 & 干预措施
High Sulforaphane Extract
干预措施: High Sulforaphane Extract (Broccoli Sprout Extract) (Drug)
Placebo
干预措施: Microcrystalline Cellulose NF (placebo) (Drug)
结局指标
主要结局
DHT Levels
时间窗: Baseline and 5 weeks
Change in serum dihydrotestosterone (DHT) levels
Testosterone Levels
时间窗: Baseline and 5 weeks
Change in testosterone (T) levels
Gene Expression of Phase II Enzymes
时间窗: Baseline and 5 weeks
Change in Phase II enzyme expression
DNA Oxidation
时间窗: Five weeks
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Lipid Oxidation
时间窗: Baseline and 5 weeks
Blood F2 Isoprostane levels
3-alpha-diol Gluconate Levels
时间窗: Baseline and 5 weeks
Change in serum 3-alpha-diol gluconate(3α-DG) levels
次要结局
未报告次要终点
研究者
Daniel Lin
Principal Investigator
Fred Hutchinson Cancer Center