USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Berkeley National Laboratory

Project Identifier: LBNL-93-107-H04

Project Title:

Effects of Diet on HDL Subclasses (see LBL-93-11-44 in 1994 database)

Principle Investigator: Dr. Paul T. Williams

Project started in: 1993

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 Institutes of Health (NIH)

Amount: $27,000 (Est.)
Comments:

Assignment #HL52617

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: 95-2-115

Number of Human Subjects in the Last Reporting Period for this Project: 105
(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 existing bodily materials that were collected for another purpose or project.

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])

To study the correlation and relationship, if any, between a low fat diet and the pattern of high density lipoprotein (HDL) subclasses, and the relationship of the response of the different apolipoprotein isoforms (genetic variants of lipoproteins among individuals) to changes in dietary fat intake.

The data used for this study were collected under another project entered in this database, "Genetic Influences on Dietary Fat Response" (LBNL-92-106-H04). Under that study subjects are asked to fill out an informational questionnaire, to adhere to a specific diet and, during the term of the study, to submit periodically to venipuncture for collection of blood for the lipoprotein analysis. The research involves no risk other than that characteristic of routine venipuncture (bruising, slight chance of infection). Use of the data from the study cited above does not increase the risk to subjects as the data is supplied anonymously. Subjects were informed in advance that their data might be used for several studies and by different investigators.