| Descriptive Information Fields | |||||
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| Brief Title † | Broccoli, Peas and PIN | ||||
| Official Title † | A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas | ||||
| Brief Summary | 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). |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Basic Science, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study | ||||
| Primary Outcome Measure † | Changes in gene expression in RNA extracted from prostate tissue [ Time Frame: Baseline, 6 months and 12 months ] | ||||
| Secondary Outcome Measure † | Changes in levels of serum prostate specific antigen (PSA) [ Time Frame: Baseline, 6 months and 12 months ] | ||||
| Condition † | Prostatic Intraepithelial Neoplasia | ||||
| Intervention † | Dietary Supplement: Broccoli Dietary Supplement: Peas |
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| MEDLINE PMIDs | 11836580, 10625170, 6337782, 10728709, 14693729, 11139137, 12742546, 9303371, 12596003, 14570043 | ||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 22 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | April 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 30 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
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| Administrative Information Fields | |||||
| NCT ID † | NCT00535977 | ||||
| Organization ID | IFR07-2004 | ||||
| Secondary IDs †† | 05/Q0101/9, 2004IFR04 | ||||
| Study Sponsor † | Institute of Food Research | ||||
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| Investigators † |
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| Information Provided By | Institute of Food Research | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | September 26, 2007 | ||||
| Last Updated Date | September 26, 2007 | ||||
