Broccoli, Peas and PIN - Full Text View

Sponsored by:	Institute of Food Research
Information provided by:	Institute of Food Research
ClinicalTrials.gov Identifier:	NCT00535977

Purpose

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	Intervention
Prostatic Intraepithelial Neoplasia	Dietary Supplement: Broccoli Dietary Supplement: Peas

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Human Intervention Trial Studying Gene Expression in High-Grade Prostatic Intraepithelial Neoplasia Following Consumption of Broccoli or Peas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets

U.S. FDA Resources

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	22
Study Start Date:	April 2005
Study Completion Date:	April 2007

Arms	Assigned Interventions
1: Experimental Dietary intervention of ITC-enriched broccoli	Dietary Supplement: Broccoli 400g ITC-enriched broccoli per week for 12 months
2: Experimental Dietary intervention of frozen peas	Dietary Supplement: Peas 400g frozen garden peas per week for 12 months

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.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535977

Sponsors and Collaborators

Institute of Food Research

Investigators

Principal Investigator:

Richard F Mithen, PhD

Institute of Food Research, Norwich

More Information

Publications:

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.

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. Review.

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. Review. No abstract available.

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.

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.

Hecht SS. Inhibition of carcinogenesis by isothiocyanates. Drug Metab Rev. 2000 Aug-Nov;32(3-4):395-411. Review.

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.

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.

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. Epub 2002 Oct 24.

Surh YJ. Cancer chemoprevention with dietary phytochemicals. Nat Rev Cancer. 2003 Oct;3(10):768-80. Review.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	IFR07-2004, 05/Q0101/9, 2004IFR04
Study First Received:	September 26, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00535977 History of Changes
Health Authority:	Norwich Research Ethics Committee UK:

Keywords provided by Institute of Food Research:

Gene expression
Prostate
Broccoli
Cancer
Men diagnosed with high-grade Prostatic Intraepithelia Neoplasia

Study placed in the following topic categories:

Prostatic Intraepithelial Neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Prostatic Intraepithelial Neoplasia
Neoplasms
Neoplasms by Histologic Type

Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on July 02, 2009