Broccoli, Peas and PIN
Primary Purpose
Prostatic Intraepithelial Neoplasia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Broccoli
Peas
Sponsored by
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
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
NCT ID
NCT00535977
First Posted
September 26, 2007
Last Updated
September 26, 2007
Sponsor
Quadram Institute Bioscience
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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