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临床试验/NCT00535977
NCT00535977已完成不适用

A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas

Quadram Institute Bioscience0 个研究点目标入组 22 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Changes in gene expression in RNA extracted from prostate tissue

研究概览

简要总结

This is a parallel human intervention trial to determine to what extent a dietary intervention of broccoli or peas can change the expression (switching on or off) of genes in prostate tissue in men diagnosed with high-grade Prostate Intraepithelial Neoplasia (PIN).

详细描述

Cancer is one of the main causes of death among humans in the world. Prostate cancer affects 20,000 men in the UK alone each year. Diet is known to be a major factor that influences risk of cancer. Therefore, changes to the diet may alter cancer risk. Cruciferous vegetables, particularly broccoli, provide the diet with a substantial source of plant chemicals called glucosinolates. Previous research has indicated that glucosinolates break down to form isothiocyanates (ITCs) that can be absorbed in the body. Further research has indicated that ITCs may protect the body against the development of prostate cancer. However, the mechanisms behind this effect are not fully understood.

ITCs are thought to be powerful anti cancer agents as they can modulate the expression (switching on or off) of specific genes involved in the removal of toxic substances such as carcinogens from the body. In this study we wish to evaluate the effect of consumption of a conventionally bred cultivar of broccoli containing high levels of ITCs on gene expression in prostate tissue to gain a better understanding of its mechanism of action. Several studies suggest a further protection against cancer amongst individuals who have a deletion of certain genes.

This pilot study comprises a 12-month intervention of either 400g ITC-enriched broccoli per week of 400g garden peas in men at high risk of developing prostate cancer. Changes in gene expression of prostate biopsy tissue will be compared before and after 6 and 12 months of intervention in both dietary groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men with a previous diagnosis of high-grade Prostatic Intraepithelial Neoplasia
  • BMI >18.5 or <35
  • Aged between 30-70 years

排除标准

  • Undergoing chemopreventive therapy
  • Receiving testosterone replacement medicines
  • Active infection requiring treatment
  • BMI <18.5 or >35
  • Diagnosed with diabetes
  • Unable to give informed consent

结局指标

主要结局

Changes in gene expression in RNA extracted from prostate tissue

时间窗: Baseline, 6 months and 12 months

次要结局

  • Changes in levels of serum prostate specific antigen (PSA)(Baseline, 6 months and 12 months)

研究者

申办方类型
Other

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