NCT04046653已完成不适用
A Pre-biopsy Window of Opportunity Trial to Measure the Dietary Bioactive Levels in the Prostate Following an Intervention With Sulforaphane and Allin Dietary Supplements
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry
研究概览
简要总结
Current research suggests that diets rich in multiple food types (such as broccoli, onions and garlic) are beneficial to our health and may reduce the risk of some cancers, including prostate cancer. The purpose of this study is to investigate the relationship between ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Scheduled for template biopsy of the prostate as part of routine investigation or staging for prostate cancer at the Norfolk and Norwich University Hospital
- •BMI between 19.5 and 35 kg/m2
- •Smokers and non-smokers
排除标准
- •Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
- •Those on warfarin treatment
- •Those diagnosed with diabetes
- •Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or viral hepatitis
- •Those allergic to any of the ingredients included in the supplements (including those with lactose intolerance)
- •Those taking additional dietary supplements or herbal remedies that could affect the study outcome.
- •Those that are unable to understand English or give informed consent
- •Parallel participation in another research project that involves dietary intervention
- •Any person related to or living with any member of the study team.
结局指标
主要结局
Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry
时间窗: 4 Weeks
Treatment-related differences in prostatic accumulation of Sulforaphane and Alliin, or their human and microbial metabolites, compared with placebo following a 4-week period of supplementation
次要结局
- 4. Changes in global gene expression in prostate tissue as measured using next generation sequencing(4 weeks)
- Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive(After 4 weeks)
- 2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry(4 weeks)
- Urinary excretion of Sulforaphane and Alliin metabolites(24-hours)
- Microbiome profile(4 weeks)
研究者
研究点 (2)
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