USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-89-225

Project Title:

Nutritional and Intestinal Consequences of Immunodeficiency States

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-DOE Federal: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Amount: $28,000 (Est.)

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: 13
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

(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])

Previous studies documented the frequent occurrence of severe, progressive malnutrition in Acquired Immune Deficiency Syndrome (AIDS). The long term goal of this study is to provide an understanding of the pathogenesis of malnutrition in AIDS, a scientific rationale for nutritional therapy, and realistic expectations for the results of such therapy. The specific aims of this proposal are to define the metabolic mechanisms underlying the alterations in body composition that occur as a result of the acquired immune deficiency syndrome, their association with active human immunodeficiency virus (HIV) infection, and their relationship to altered release of cytokines. The centerpiece of these studies will be precise measurements of body composition which will allow precise determination of depletion or repletion. Elemental body compositions will be determined by whole body counting and in vivo neutron activation analysis. Subjects will be exposed three times per year to ionizing radiation including neutrons, gamma-rays and electrons. 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.