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Clinical Trials: Healthy Volunteer
IRB No. 01-262-1 (Dr. Marion Frank, PI): Human Salty and Bitter Taste Mechanisms
Study description not available
IRB No. 06-229S-1 (Dr. Martin Cherniack, PI): Health Improvement Through Training and Employee Control (HITEC)
This study compares two different approaches to combining workplace safety and health with personal health improvement. The primary focus is on improvement of musculosketal health (mobility and fitness, preventing and controlling joint disease, and work risk reduction), and the secondary focus is on depression and mental health. One approach relies on traditional health promotion, where a management sponsored program offers an educational package and professional review of work organization and ergonomics. The second approach involves developing groups within the workforce (Employee Sponsored Groups or ESPs) that will determine and construct workplace health and safety and personal health programs. The study involves a comparison of cost, measures of health status, and evaluation of the effectiveness of the workforce planning groups. The direct involvement of the workers compensation insurance carrier in the study team is intended to produce realistic and respected agreements about health program conduct and content between the workforce and management. There is a significant economic and econometric component, which is designed to link health and process outcomes to rate structure.
IRB No. 13-031-3 (Dr. Lance Bauer, PI): Alcohol Risk Genes and Obesity Risk
Examine whether teen age girls who are overweight or obese differ from other girls of the same age in genes and brain function, and if these differences are related to their alcohol use
IRB No. 14-194J-3 (Dr. George Kuchel, PI): Impact of aging on gene expression and RNA splice variants in peripheral blood cells
The primary objective of this IRB proposal is to obtain preliminary feasibility and pilot data for the submission of a competitive renewal this fall for Dr Palucka's HIPC U19 grant currently funded by NIH. PRIMARY HYPOTHESIS We will be able to gain a comprehensive view of the genomic alterations associated with aging and frailty using immunological and system biology approaches. Furthermore, we theorize that these changes will be associated with specific microbiome composition. SPECIFIC AIMS This is a single-center exploratory study to carry out transcriptional and microbiome profiling analysis to gain a comprehensive view of genomic alterations associated with aging and frailty. Aim 1: To collect the samples from well-characterized volunteer cohorts. Aim 2: To establish whole blood isoform profiles. Aim 3: To establish epigenetic profiles of PBMCs and sorted blood cells Aim 4: To characterize microbiome in saliva and stool samples. SIGNIFICANCE It becomes critically important to apply system biology approaches and in-depth genomics to understand aging and related alterations. Identifying the immunologic parameters that correlate with or predict immune alterations will have a significant impact on the increased understanding of disease physiology in older age and eventually novel biomarkers and targets for therapy. RELEVANCE Recent technological breakthroughs have made the study of biological systems on a large scale a reality, thus offering unprecedented opportunities to comprehensively profile genome and immune responses in human subjects. A major challenge when engaging in such studies is to establish baseline values in subjects over time under "healthy" conditions. This data will be used as a basis for design of futures studies identifying changes occurring in response to challenge as for example acute infection or vaccination.