USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-89-224

Project Title:

The Effects of Strength Training and Weight Reduction on Bone and Muscle Mass in Postmenopausal Women

Principle Investigator: Dr. Ruimei Ma

Project started in: 1989

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.

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: 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 examines the effects of a hypocaloric diet and strength training exercise on changes in bone and muscle mass in postmenopausal Caucasian women. Two groups of women will be studied: 1) women less than 110% of ideal body weight (IBW). The women in this group will be randomly assigned to either a sedentary control group or a strength training group for 12 months. 2) overweight women (130-140% of IBW) who will lose weight over the 12-month period. The women in this group will be randomly assigned to either a weight loss by diet alone group or a weight loss by diet and strength training group. We will use state-of-the-art techniques to quantify total body calcium, nitrogen, potassium, carbon, regional bone density, body fat, muscle mass, regional muscle mass, calcium absorption, nutritional status, endocrine status and fitness level. This study will be the first to examine longitudinal changes in body composition, muscle strength and bone density by increasing muscle mass through strength training and decreasing it through weight loss. A total of 100 subjects will be studied. Each of these subjects will undergo in vivo neutron activation (IVNA) analysis at the beginning and the end of the one year program. 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 be extrapolation from much higher doses.