USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-90-107-H02

Project Title:

Weight Set Point and HDL Levels in Long-Distance Runners (see LBL-93-5-55 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1990

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-DOE Federal: National Heart, Lung, and Blood Institute (NHLBI)

Amount: $363,268 (Est.)
Comments:

Assignment number: HL-45652

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: June 09, 1995
IRB Approval Number: 95-6-107

Number of Human Subjects in the Last Reporting Period for this Project: 250
(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:

  Heparin is administered according to the standard medical procedure for a lipase activity test.

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])

The investigator proposes to examine the difference(s) in diet and lipoprotein metabolism in previously overweight or naturally lean men and women who run or live sedentary lifestyles. The goal is to better understand the relationship between lipoprotein metabolism and weight set-point.

Responses to a survey and analysis of diet records will be correlated with the results of clinical blood testing. Laboratory tests will include standard lipoprotein and cholesterol screening, including for some subjects a separately approved post-heparin lipase activity test.

The risks involved are those common to routine clinical venipuncture (bruising, slight chance of infection) and to the clinical use of the post-heparin lipase activity test (same as venipuncture; very rarely, allergic reaction).