USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-94-115

Project Title:

Effects of Crucifera Intake

Principle Investigator: Dr. Kenneth W. Turteltaub

Project started in: 1994

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Explanation:

No direct funding. We participated as part of a pilot study.

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: September 19, 1994
IRB Approval Number: 94-115

Number of Human Subjects in the Last Reporting Period for this Project: 10
(Reporting periods vary.)

Type of Human Subjects Involvement:

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

Questionnaires, Surveys, Epidemiological Studies:

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies.

• Use of data collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The purpose of this study is to determine whether increased exposure to vegetables of the Crucifera family(cauliflower,broccoli and cabbage) results in measurable improvements in factors which can affect carcinogenesis in man, including the adduct induction of bile, mutagenicity of the urine and bile, and prevention of the formation of DNA adducts. Epidemiological studies have shown a strong association between consumption of vegetables of the Crucifera family and a reduced risk of cancer. Animal studies have also suggested that these vegetables may be protective where cancer is concerned. Understanding if these vegetables are effective preventative agents for colon cancer and how best to consume these vegetables is critical to making recommendation on the use of the diet in cancer prevention. This study will specifically attempt to determine if a set of Crucifera vegetables can influence measurable biomarkers that are used to judge colon cancer risk in humans and thus will help determine if this set of vegetables are the agents responsible for the protective effect noted in other studies. This study is a collaboration between Lenore Kohlmeier, Ph.D. (University of North Carolina, Chapel Hill), Robert Sandler, M.D., M.P.H., John Worzelmann, M.D, Dr. Jane Gallager (US Environmental Protection Agency), and Dr. K. Turteltaub (LLNL). LLNL's involvement in this study will be solely in the analysis of DNA adducts present in the colon tissue samples. Briefly, human subjects (5 non-smoking males and 5 non-smoking females) 45 - 65 years of age and free of thyroid function disorders, will be given isocaloric diets reflecting the energy composition of the normal diet. Five subjects (the treated group) will be given 500 g Crucifera vegetables (cauliflower, broccoli, and cabbage) added in fresh and cooked forms to the standard diet. The other five subjects will receive only the control diets. Blood, urine, bile, stool and rectal biopsy tissues will be collected during a physical examination and a one night stay in the hospital will be required. Tissue samples will be collected by the physician; they will be frozen and sent to LLNL for analysis. DNA will be purified using standard extraction protocols involving phenol extraction and adduct analysis will be carried out using 32P-postlabeling.