USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-93-252

Project Title:

Validation of a Method for Estimating Muscle Protein Mass and Muscle Protein Breakdown in Humans

Principle Investigator: Dr. Ruimei Ma

Project started in: 1993

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Funding was not received for this project and no subjects were studied.

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: October 04, 1995

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

This study will investigate whether the proposed diagnostic technique (isotopic dilution of 3-methyl-histidine (3MH)) can be used to directly measure the mass of muscle contained in the body of humans. These results will be correlated with body compositions determined by whole body counting (TBK), total body water measurement (TBW), and neutron activation analysis (TBN and TBC) at BNL. Since the measurement of TBK, TBW, TBC and TBN provides the most definitive techniques for studying body composition, the present study will determine whether the use of saliva samples will suffice for estimating the decay curve of 3MH, and hence can be used for the determination of muscle mass in vivo. By mathematically modeling the change in the stable iosotope in the salivary fluid, the muscle mass as well as the breakdown of this muscle can be measured. A total of 20 subjects will be studied. They will be measured only once. Elemental body compositions will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. 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 those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.