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OpenTrials
Completed

NCT Number: NCT00535977

Broccoli, Peas and PIN

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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Key information

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broccoli

Dietary Supplement

400g ITC-enriched broccoli per week for 12 months

Peas

Dietary Supplement

400g frozen garden peas per week for 12 months

Primary outcomes

  1. Changes in gene expression in RNA extracted from prostate tissue

    Time frame: Baseline, 6 months and 12 months

Secondary outcomes

  1. Changes in levels of serum prostate specific antigen (PSA)

    Time frame: Baseline, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Quadram Institute Bioscience

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 27, 2007
Registry last updated
Sep 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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