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Broccoli, Peas and PIN

Primary Purpose

Prostatic Intraepithelial Neoplasia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Broccoli
Peas
Sponsored by
Quadram Institute Bioscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostatic Intraepithelial Neoplasia focused on measuring Gene expression, Prostate, Broccoli, Cancer, Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Dietary intervention of ITC-enriched broccoli

    Dietary intervention of frozen peas

    Outcomes

    Primary Outcome Measures

    Changes in gene expression in RNA extracted from prostate tissue

    Secondary Outcome Measures

    Changes in levels of serum prostate specific antigen (PSA)

    Full Information

    First Posted
    September 26, 2007
    Last Updated
    September 26, 2007
    Sponsor
    Quadram Institute Bioscience
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00535977
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Quadram Institute Bioscience

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Intraepithelial Neoplasia
    Keywords
    Gene expression, Prostate, Broccoli, Cancer, Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Dietary intervention of ITC-enriched broccoli
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Dietary intervention of frozen peas
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Broccoli
    Intervention Description
    400g ITC-enriched broccoli per week for 12 months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Peas
    Intervention Description
    400g frozen garden peas per week for 12 months
    Primary Outcome Measure Information:
    Title
    Changes in gene expression in RNA extracted from prostate tissue
    Time Frame
    Baseline, 6 months and 12 months
    Secondary Outcome Measure Information:
    Title
    Changes in levels of serum prostate specific antigen (PSA)
    Time Frame
    Baseline, 6 months and 12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard F Mithen, PhD
    Organizational Affiliation
    Institute of Food Research, Norwich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11836580
    Citation
    Chiao JW, Chung FL, Kancherla R, Ahmed T, Mittelman A, Conaway CC. Sulforaphane and its metabolite mediate growth arrest and apoptosis in human prostate cancer cells. Int J Oncol. 2002 Mar;20(3):631-6. doi: 10.3892/ijo.20.3.631.
    Results Reference
    background
    PubMed Identifier
    10625170
    Citation
    Cotton SC, Sharp L, Little J, Brockton N. Glutathione S-transferase polymorphisms and colorectal cancer: a HuGE review. Am J Epidemiol. 2000 Jan 1;151(1):7-32. doi: 10.1093/oxfordjournals.aje.a010124.
    Results Reference
    background
    PubMed Identifier
    6337782
    Citation
    Fenwick GR, Heaney RK, Mullin WJ. Glucosinolates and their breakdown products in food and food plants. Crit Rev Food Sci Nutr. 1983;18(2):123-201. doi: 10.1080/10408398209527361. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10728709
    Citation
    Gamet-Payrastre L, Li P, Lumeau S, Cassar G, Dupont MA, Chevolleau S, Gasc N, Tulliez J, Terce F. Sulforaphane, a naturally occurring isothiocyanate, induces cell cycle arrest and apoptosis in HT29 human colon cancer cells. Cancer Res. 2000 Mar 1;60(5):1426-33.
    Results Reference
    background
    PubMed Identifier
    14693729
    Citation
    Giovannucci E, Rimm EB, Liu Y, Stampfer MJ, Willett WC. A prospective study of cruciferous vegetables and prostate cancer. Cancer Epidemiol Biomarkers Prev. 2003 Dec;12(12):1403-9.
    Results Reference
    background
    PubMed Identifier
    11139137
    Citation
    Hecht SS. Inhibition of carcinogenesis by isothiocyanates. Drug Metab Rev. 2000 Aug-Nov;32(3-4):395-411. doi: 10.1081/dmr-100102342.
    Results Reference
    background
    PubMed Identifier
    12742546
    Citation
    Hintze KJ, Keck AS, Finley JW, Jeffery EH. Induction of hepatic thioredoxin reductase activity by sulforaphane, both in Hepa1c1c7 cells and in male Fisher 344 rats. J Nutr Biochem. 2003 Mar;14(3):173-179. doi: 10.1016/s0955-2863(02)00282-6.
    Results Reference
    background
    PubMed Identifier
    9303371
    Citation
    Key TJ, Silcocks PB, Davey GK, Appleby PN, Bishop DT. A case-control study of diet and prostate cancer. Br J Cancer. 1997;76(5):678-87. doi: 10.1038/bjc.1997.445.
    Results Reference
    background
    PubMed Identifier
    12596003
    Citation
    Mithen R, Faulkner K, Magrath R, Rose P, Williamson G, Marquez J. Development of isothiocyanate-enriched broccoli, and its enhanced ability to induce phase 2 detoxification enzymes in mammalian cells. Theor Appl Genet. 2003 Feb;106(4):727-34. doi: 10.1007/s00122-002-1123-x. Epub 2002 Oct 24.
    Results Reference
    background
    PubMed Identifier
    14570043
    Citation
    Surh YJ. Cancer chemoprevention with dietary phytochemicals. Nat Rev Cancer. 2003 Oct;3(10):768-80. doi: 10.1038/nrc1189.
    Results Reference
    background
    PubMed Identifier
    18596959
    Citation
    Traka M, Gasper AV, Melchini A, Bacon JR, Needs PW, Frost V, Chantry A, Jones AM, Ortori CA, Barrett DA, Ball RY, Mills RD, Mithen RF. Broccoli consumption interacts with GSTM1 to perturb oncogenic signalling pathways in the prostate. PLoS One. 2008 Jul 2;3(7):e2568. doi: 10.1371/journal.pone.0002568.
    Results Reference
    derived

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    Broccoli, Peas and PIN

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