Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Broccoli, Peas and PIN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00535977
Recruitment Status : Completed
First Posted : September 27, 2007
Last Update Posted : September 27, 2007
Sponsor:
Information provided by:
Quadram Institute Bioscience

Tracking Information
First Submitted Date  ICMJE September 26, 2007
First Posted Date  ICMJE September 27, 2007
Last Update Posted Date September 27, 2007
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2007)
Changes in gene expression in RNA extracted from prostate tissue [ Time Frame: Baseline, 6 months and 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2007)
Changes in levels of serum prostate specific antigen (PSA) [ Time Frame: Baseline, 6 months and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli, Peas and PIN
Official Title  ICMJE 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Prostatic Intraepithelial Neoplasia
Intervention  ICMJE
  • Dietary Supplement: Broccoli
    400g ITC-enriched broccoli per week for 12 months
  • Dietary Supplement: Peas
    400g frozen garden peas per week for 12 months
Study Arms  ICMJE
  • Experimental: 1
    Dietary intervention of ITC-enriched broccoli
    Intervention: Dietary Supplement: Broccoli
  • Experimental: 2
    Dietary intervention of frozen peas
    Intervention: Dietary Supplement: Peas
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2007)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535977
Other Study ID Numbers  ICMJE IFR07-2004
05/Q0101/9
2004IFR04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Quadram Institute Bioscience
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard F Mithen, PhD Institute of Food Research, Norwich
PRS Account Quadram Institute Bioscience
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP