Personalized Nutrition and Medicine

Director: James A. Kaput, Ph.D.

The Division of Personalized Nutrition and Medicine (DPNM) is charged with developing strategies, methods, and resources for improving individual and public health. The need for this Division and research paradigm resulted from data generated by the human genome and HapMap projects. These international efforts laid the foundation for one of the most significant scientific contributions to humankind—an evidence-based understanding that while humans are genetically similar, each retains a unique genetic identity that contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. Parallel molecular genetic studies have demonstrated that nutrient and environmental chemicals directly or indirectly regulate the expression of one’s genetic makeup.

While the research strategies of the 20th century yielded data and knowledge that extended our average lifespan and improved personal and public health, much of that knowledge was based on the average response of a population to a food, nutrient, or environmental chemical, or the average risk for carrying a specific allele of a gene involved in disease. Such knowledge may or may not be applicable to an individual with different genotypes or environmental exposures.

The overall goals of the DPNM are to develop and implement research strategies that account for genetic, environmental, and cultural diversity that influence expression of genetic makeups and produce knowledge for improving personal and public health. These overarching goals will be met with three parallel efforts that develop:

• Integration of omics methodologies to assess an individual’s health status and, as importantly, susceptibility to specific chronic conditions influenced by environmental factors including diet
• Means to capture and assess an individual’s nutritional, environmental, and activity exposures
• Classification algorithms that integrate the data from omics and environmental assessments that will result in evidence-based and validated biomedical decision making

The Division has two branches—Biometry and Biology. The main function of the Biometry branch is to develop biometrical methods for all aspects of the FDA’s mission, goals, and objectives. A subgroup within the Division analyzes all data from the National Toxicology Program (NTP). The Biology branch is focusing on the broad areas of pharmacogenomics and nutrigenomics—how individuals respond to drugs and nutrients in foods.

Ongoing Research Projects 

• Application of Biometrical Procedures for NTP Projects (S00175)
• Benefit/Risk Classification Models for Regulatory Decision Making in Personalized Medicine (E0722001)
• Biostatistical Modeling for Food Protection Plan (S00703)
• Delta Vitamin Obesity Prevention Summer Camp (E0733001)
• Developmental Toxicity of Bitter Orange in Rats (E0214701)
• Developmental Toxicity of Environmental Contaminants in Folate-Deficient Mice - Preliminary Experiment (P00696)
• Evaluating the Statistical Significance of Treatments on a Group of Correlated Genes (E0723601)
• Integrated Genomics Knowledge Base for Rapid Threat Assessment of Enteric Pathogens: Salmonella (E0733701)
• Mechanisms of Gender Differences in Aspirin Effects: Metabolizing Enzymes and Therapeutic Targets (E0727101)
• Micronutrient Involvement in Differentiation of Multipotent Mesenchymal Stem Cells into Adipocytes through MicroRNA Regulation (P00720)
• Modification and Application of Quantitative Risk-Assessment Techniques to FDA-Regulated Products (S00174)
• Obesity Prevention Summer Program: Feasibility of Implementing a Multi-Component Obesity Prevention Intervention at a Youth Program in the Mississippi Delta (E0729601)
• Optimal Tree-Based Ensemble Methods for Class Prediction (E0722101)
• Physiological Effects of Bitter Orange in Rats (E0214901)
• Preliminary Study of to Determine the Physiological and Cardiovascular Effects of Citrus Aurantium in Mini-Pigs (P00721)
• Sex Differences in Molecular Biomarkers for Individualized Treatment of Non-Gender-Specific Disease: A Novel Classification Algorithm for the Development of Genomic Signatures from High-Dimensional Data (E0727901)
• Yellow Agouti Mouse Breeding Colony (E0728801)

The NCTR Annual Report contains information on the latest accomplishments and plans for NCTR's Division of Personalized Nutrition and Medicine as well as project and publication listings.