USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-92-106-H04

Project Title:

Genetic Influences on Dietary Fat Response (see LBL-93-2-93 in 1994 database)

Principle Investigator: Dr. Ronald M. Krauss

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: Children's Hospital Oakland Research Institute

Amount: $211,400 (Est.)

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: February 17, 1995
IRB Approval Number: 95-2-104

Number of Human Subjects in the Last Reporting Period for this Project: 28
(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.
• Use of existing data that were collected for another purpose or 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])

OBJECTIVES

The objective of this study is to investigate the role of genetic factors in influencing lipoprotein responses to varying dietary fat intake and to assess the ultimate effects of such gene-diet interactions on atherosclerosis. Blood tests and surveys are used initially to characterize subjects and their families; individuals meeting certain criteria may be invited to participate in experimental protocols. Some of the subjects may be minors.

METHODOLOGY

LBNL involvement is limited to analysis of serum samples and surveys from the study.

INVOLVEMENT OF AND RISKS TO HUMAN SUBJECTS

LBNL involvement is limited to the analysis of survey data and serum samples collected at another site. No additional risk to subjects is incurred by LBNL analysis of samples.