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Broccoli, Peas and PIN

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ClinicalTrials.gov Identifier: NCT00535977
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
Information provided by:
Quadram Institute Bioscience

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).

Condition or disease Intervention/treatment Phase
Prostatic Intraepithelial Neoplasia Dietary Supplement: Broccoli Dietary Supplement: Peas Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas
Study Start Date : April 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Dietary intervention of ITC-enriched broccoli
Dietary Supplement: Broccoli
400g ITC-enriched broccoli per week for 12 months

Experimental: 2
Dietary intervention of frozen peas
Dietary Supplement: Peas
400g frozen garden peas per week for 12 months

Primary Outcome Measures :
  1. Changes in gene expression in RNA extracted from prostate tissue [ Time Frame: Baseline, 6 months and 12 months ]

Secondary Outcome Measures :
  1. Changes in levels of serum prostate specific antigen (PSA) [ Time Frame: Baseline, 6 months and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535977

Sponsors and Collaborators
Quadram Institute Bioscience
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Principal Investigator: Richard F Mithen, PhD Institute of Food Research, Norwich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00535977    
Other Study ID Numbers: IFR07-2004
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007
Keywords provided by Quadram Institute Bioscience:
Gene expression
Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia
Additional relevant MeSH terms:
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Carcinoma in Situ
Prostatic Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type