USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-89-107-H03

Project Title:

Effects of Exercise, Diet, and Fat Loss on Lipoproteins (see LBL-93-2-72 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1989

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:

Work with human subjects is limited to retrospective analysis of data collected as part of other studies reported in this database. See abstract.

Funding Sources:

Non-DOE Federal: National Institutes of Health (NIH)

Amount: $81,900 (Est.)
Comments:

Research Career Development Award Assignment # HL-02183

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 18, 1994
IRB Approval Number: 94-2-80 (DC'd 2/94)

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

Type of Human Subjects Involvement:

Questionnaires, Surveys, Epidemiological Studies:

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

• 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])

The investigator discontinued the IRB approval for this Research Career Development Award project in January 1995, because funding had expired.

The objective was to study the correlation and relationship, if any, between various exercise, weight-loss and diet treatment regimens for coronary heart disease to existing data of plasma lipid concentrations, lipoprotein profiles, and specific plasma enzymes involved in lipid metabolism. The interaction with human subjects was limited to retrospective analysis of data collected as part of other studies referenced elsewhere in this database: "The National Runner's Health Study" (LBNL-91-107-H01), "Lipoprotein Subfractions and Coronary Heart Disease During 25-Year Follow-Up" (LBNL-88-107-H07), and "Metabolic and Genetic Origins of Lipoprotein Subclasses" (LBNL-79-106-H02). The number of subjects and the risks to which they were exposed, if any, are described as part of these projects.