A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Sulphate level
研究概览
简要总结
This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.
详细描述
Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.
The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.
Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.
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
- None
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
- 是
入选标准
- •Scheduled for TPB as part of routine investigation or staging for prostate cancer
- •Aged 18-80 years
- •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 hepatitis
- •Those allergic to any of the ingredients of the broccoli soups
- •Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
- •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
Sulphate level
时间窗: Biopsy on a single occasion at ≥ 4 weeks
Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
次要结局
- Redox status of phosphatase proteins(Biopsy on a single occasion at ≥ 4 weeks)
- ADP(Biopsy on a single occasion at ≥ 4 weeks)