USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory

Project Identifier: LLNL-95-115

Project Title:

Determining Metabolism Differences by Urine Analysis

Principle Investigator: Dr. James S. Felton

Project started in: 1995

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Animal experiments are being done first to discover minimum/maximum sensitivity for human urine detection.

Funding Sources:

Non-DOE Federal: National Cancer Institute (NCI)

Amount: $50,000 (Est.)
Comments:

Very small amount of 1,400K for program project.

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: May 17, 1995
IRB Approval Number: 95-115

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

• Other internal use of chemical substances:

  Planned: Toxicology of Foods.

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.

Other use of human subjects:

Food toxicology research. All commonly eaten foods and normal urine collection.

(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 objectives of this work are to understand the human susceptibility to the cooked food containing carcinogenic heterocyclic amines. Individuals will eat normally cooked meat products, primarily chicken, and their urine will be collected over a 10 hour time period. Subjects will be exposed to food. Unfortunately, cooked food contains 1-500 ppb of very potent carcinogens and the subjects will be exposed up to 200 ug of compounds similar to PhIP (2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine) at a single meal. Individuals will undergo the risk of eating carcinogens, but no more than they do if they are not vegetarians.