USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-89-222

Project Title:

New and Old Models in Body Composition: Ethnic Specificity

Principle Investigator: Dr. Ruimei Ma

Project started in: 1989

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: St. Luke's Roosevelt Hospital

Amount: $71,000 (Est.)
Comments:

Funding is a subcontract from St. Luke's Roosevelt Hospital, whose research is funded by National Institute of Diabetes and Digestive and Kidney Disease (NIDDK).

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: July 12, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 33
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

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.

(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])

Obesity and its associated medical complications represent a major health problem in black women. Evaluating the prevalence and underlying pathogenesis of obesity in black women requires accurate estimates of body fat and the metabolically active tissue mass. The aims of this project are to 1) expand our subject pool to provide definitive coefficients for two-compartment models in women as a function of age, ethnicity and body fat; 2) model resting metabolic rate in relation to extensive body composition measurements in this diverse group of subjects; and 3) critically evaluate body composition methodology and models in tracking compartmental changes in obese women losing weight on a hypocaloric diet over three months. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Human subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as that delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.