2004 Annual Report 1.What major problem or issue is being resolved and how are you resolving it (summarize project aims and objectives)? How serious is the problem? What does it matter? The brain develops with a time course of events that is influenced by many factors, prominent among which are nutritional status and dietary factors. The primary goal of this research is to determine the effects of diet and nutritional status on brain development and function in children. We are particularly interested in learning how to best "feed the brain" to maximize development and cognitive function in children. Studies currently focus upon:. 1)the effects of breast feeding and formula feeding of normal infants born after a full-length pregnancy (term infants);. 2)development of new diets that promote brain development and function in normal babies born prior to full term (pre-term); and. 3)learning the effects of nutritional status and diet intake of school children on brain function, especially as it relates to learning, memory, attention, and intelligence (generically referred to as cognition). Our research uses standardized state-of-the-art methodology and equipment to assess dietary intake and nutritional status of children. Research collaborators include nutritionists and child psychologists/ neuroscientists who work as a team to address important questions related to the influence of nutritional status and dietary intake on brain function. Our studies involve obtaining responses to a battery of physiological and behavioral tests. The tests are designed to assess specific brain functions and to predict future central nervous system function in such important areas as language acquisition, math skills, learning, memory, attention, and intelligence. These tests are designed to account for factors such as age and gender. Thus, there are several major problems being addressed by these studies. We are:. 1)determining the effects of diet and nutrition on brain development and brain function; and. 2)learning the effects of complete diets, specific nutrients, and other dietary factors on brain function. Armed with this knowledge, it will eventually be possible to design diets that work to optimize normal brain development and maximize cognitive potential. The questions being addressed in this program are very important and consistent with the National Program goals. Unfortunately, there are very few researchers in this area and virtually no studies being conducted to address many important questions related to nutrition/dietary intake and human brain development/function. For example, there are more than 350,000 infants born in the low birth-weight range in the US each year. These are essentially normal infants, but because they were born prematurely, their brain growth and development is retarded relative to infants born after a full-term pregnancy. Normally, brain development would be fueled by nutrients and specific factors that cross through the placenta from the mother to the fetus, and many of these same factors are also present in milk produced by mothers who have full-length pregnancies. The identity and actions of these factors are only partially understood, and most of our knowledge has come from studies of breast milk. Currently marketed infant formulas do not contain most of these factors, either because of expense or because their functions have not been documented sufficiently. Even though there are special formulas made just for pre-term infants, they lack many of the factors thought to be important for normal brain development. Thus, many of these children grow up with central nervous system defects that result in hyperactivity and disorders of cognition and attention. This not only impacts the quality of life for these children and their families, but has a significant negative societal impact in terms of lost work potential, increased stress on school systems, and increased public expenses. Thus, this is a serious problem that carries with it life-long consequences. Two studies at the Arkansas Children's Nutrition Center focus on the development of new diets that will promote brain development and function. Other studies address similar important questions related to optimizing brain development and function through diet and nutrition. 2.List the milestones (indicators of progress) from your Project Plan. This research includes three ongoing projects studying the effects of diet and nutrition on psychological and biological functioning in infants and children. Two are longitudinal studies [participants assessed multiple times across 6 year (Soy Project) and 3 year (Formula Supplement Project) periods] comparing growth, body composition, and cognitive development of infants. The third evaluates the effects of USDA school breakfast and lunch diets on neurophysiologic and cognitive functions important for learning in school-aged children. The milestones for each project are provided below. Year 1 (FY 2004): Office of Scientific Quality Research (OSQR) peer review of the project, consisting of three research projects, completed and certified. Project 1: Soy-Based Formula Studies. This project compares growth, body composition, and cognitive development of infants receiving breast milk, milk-based formula, or soy-based formula over their first six years of life (it will take 7-8 years total). It will provide the first, systematic comparative evaluation of the acute and longer term effects of these basic diets on these fundamental physical, physiological, and cognitive aspects of health and development. Year 2 (FY 2005): Recruitment for this study (total n=380) will be ~ 30% complete. We anticipate 3-4 abstracts and/or brief reports based on preliminary diet-related findings in 3-month-old infants will be submitted. These initial reports will deal with brain electrical activity measures (event-related potentials) of language development and the comparative development of brain electrical activity. Year 3 (FY 2006): It is expected that 60% (n=230) of the projected study population will be recruited. We anticipate 3-4 abstracts and/or brief reports based on additional preliminary diet-related findings in 3-month-old infants, including evaluations of data related to auditory startle responses and social interactions. Preliminary findings in 6-month-old infants will also be submitted. These reports will include comparisons with 3-month data to track diet-related developmental differences in brain electrical activity measures (event-related potentials) of language development and brain electrical activity assessed during resting periods. Year 4 (FY 2007): It is expected that 90% (n=340) of the projected study population will be recruited by the end of this year. We anticipate 3-4 abstracts and/or brief reports based in 3- and 6-month-old infants, related to auditory startle responses and social interactions. Preliminary findings in 9- and 12-month-old infants will also be submitted. These reports will include comparisons with earlier visits to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Initial analyses of metabolic data (plasma and urine levels of soy phytochemicals and their metabolites) collected in 3- and 6-month-old infants will be conducted and preliminary findings reported. Year 5 (FY 2008): Complete subject recruitment for the study. Data from the 3-month-old infants will be completed and written up for publication. We anticipate 3-4 abstracts and/or brief reports based on additional diet-related findings in 6-, 9-, and 12-month-old infants on measures listed above. Up-dating analyses and reports of metabolic data (plasma and urine levels of soy phytochemicals and their metabolites) collected in 3- and 6-month-old infants. Project 2: Low Birth Weight Formula Supplement Study. This project deals with enhancing the composition of infant formula through the addition of specific sugars (monosaccharides) normally available to developing infants through the placenta or via breast milk. The aim is to improve brain development and function in premature low birth weight infants by providing nutritional benefits not currently available in formula. Year 2 (FY 2005): The initial phase of this project involved collecting milk samples from breast-feeding mothers and determining the composition at different gestational periods to formulate the supplement. By the end of 2005, all samples will have been collected, processed, and the supplement formulated, manufactured, and tested. The milk composition analyses will be published. We will begin recruitment and study (growth, health, cognitive and physiological measures) of term and low birth weight infants. Year 3 (FY 2006): We expect to recruit one-third (n=95) of the projected study population. 2-3 abstracts and/or brief reports based on initial neonatal assessments and additional preliminary diet-related findings in 6-month-old infants will be submitted. These will focus on diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Year 4 (FY 2007): We expected to recruit two-thirds (n=190) of the projected study population. Abstracts and brief reports based on updated initial and 6-month-old infants will be submitted. These will continue to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods, and will include evaluations of data related to auditory startle responses and social interactions. Preliminary findings in 12-month-old infants will be submitted. These reports will include comparisons with neonatal and 6-month data to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Year 5 (FY 2008): It is expected that recruitment will be completed within the first half of this year. Data from the initial neonatal assessments will be submitted for publication. We anticipate 3-4 abstracts and brief reports based on updated findings in 6- and 12-month-old infants on measures listed above. These reports will include comparisons across study visits to track diet-related developmental differences study measures, e.g., brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Preliminary findings in 2-year-old babies will also be analyzed and submitted for presentation and publication. These reports will include comparisons across visits to track diet-related developmental differences in brain electrical activity measures of language development, brain electrical activity assessed during resting periods, and other behavioral and physiological measures. Project 3: School Breakfast-Lunch Studies. This series of studies is designed to evaluate the effects of USDA school breakfast and lunch diets on neurophysiologic and cognitive functions important for learning in school-aged children and provide data to help improve the influence of these food assistance programs on processes important in learning. Year 2 (FY 2005): Recruitment and data analysis for this project will be completed, and the initial full-study papers summarizing the results from ~ 100 children will be submitted for publication. These papers will compare children who skip breakfast with those who have eaten breakfast on measures relating autonomic (e.g., heart rate, respiration) and brain electrical activity (EEG), attention, memory, and performance. The protocol for the next study in this series will be submitted for IRB approval, and piloting of the protocol conducted, and recruitment (n=185, ~ 6/month; 20% attrition rate) and data acquisition initiated. Year 3 (FY 2006): We anticipate 2-3 articles on math paradigm and memory data (EEG and performance measures) from the initial study. We expect to recruit half (n=50) of the subjects for the second study. 2-3 abstracts and/or brief reports on physiological (EEG, autonomic measures) and performance (reaction time, response accuracy) data will be submitted. Year 4 (FY 2007): It is expected that subject recruitment for this study will be completed. 2-3 abstracts and brief reports will be submitted. Year 5 (FY 2008): 2-3 full-study papers summarizing the results from ~ 150 children will be submitted. Development of the protocol for the next study in this series will be submitted for IRB approval. 3.Milestones: A. List the milestones (from the list in Question #2) that were scheduled to be addressed in FY 2004. Year 1 (FY 2004): Office of Scientific Quality Research (OSQR) peer review of the project, consisting of three research projects, completed and certified. This milestone was fully accomplished during FY 2004. B. List the milestones (from the list in Question #2) that you expect to address over the next 3 years (FY 2005, 2006, & 2007). Project 1: Soy-Based Formula Studies. Year 2 (FY 2005): Recruitment for this study (total n=380) will be ~ 30% complete. We anticipate 3-4 abstracts and/or brief reports based on preliminary diet-related findings in 3-month-old infants will be submitted. These initial reports will deal with brain electrical activity measures (event-related potentials) of language development and the comparative development of brain electrical activity. Year 3 (FY 2006): It is expected that 60% (n=230) of the projected study population will be recruited. We anticipate 3-4 abstracts and/or brief reports based on additional preliminary diet-related findings in 3-month-old infants, including evaluations of data related to auditory startle responses and social interactions. Preliminary findings in 6-month-old infants will also be submitted. These reports will include comparisons with 3-month data to track diet-related developmental differences in brain electrical activity measures (event-related potentials) of language development and brain electrical activity assessed during resting periods. Year 4 (FY 2007): It is expected that 90% (n=340) of the projected study population will be recruited by the end of this year. We anticipate 3-4 abstracts and/or brief reports based in 3- and 6-month-old infants, related to auditory startle responses and social interactions. Preliminary findings in 9- and 12-month-old infants will also be submitted. These reports will include comparisons with earlier visits to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Initial analyses of metabolic data (plasma and urine levels of soy phytochemicals and their metabolites) collected in 3- and 6-month-old infants will be conducted and preliminary findings reported. Project 2: Low Birth Weight Formula Supplement Study. Year 2 (FY 2005): The initial phase of this project involved collecting milk samples from breast-feeding mothers and determining the composition at different gestational periods to formulate the supplement. By the end of 2005, all samples will have been collected, processed, and the supplement formulated, manufactured, and tested. The milk composition analyses will be published. We will begin recruitment and study (growth, health, cognitive and physiological measures) of term and low birth weight infants. Year 3 (FY 2006): We expect to recruit one-third (n=95) of the projected study population. 2-3 abstracts and/or brief reports based on initial neonatal assessments and additional preliminary diet-related findings in 6-month-old infants will be submitted. These will focus on diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Year 4 (FY 2007): We expected to recruit two-thirds (n=190) of the projected study population. Abstracts and brief reports based on updated initial and 6-month-old infants will be submitted. These will continue to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods, and will include evaluations of data related to auditory startle responses and social interactions. Preliminary findings in 12-month-old infants will be submitted. These reports will include comparisons with neonatal and 6-month data to track diet-related developmental differences in brain electrical activity measures of language development and brain electrical activity assessed during resting periods. Project 3: School Breakfast-Lunch Studies. Year 2 (FY 2005): Recruitment and data analysis for this project will be completed, and the initial full-study papers summarizing the results from ~ 100 children will be submitted for publication. These papers will compare children who skip breakfast with those who have eaten breakfast on measures relating autonomic (e.g., heart rate, respiration) and brain electrical activity (EEG), attention, memory, and performance. The protocol for the next study in this series will be submitted for IRB approval, and piloting of the protocol conducted, and recruitment (n=185, ~ 6/month; 20% attrition rate) and data acquisition initiated. Year 3 (FY 2006): We anticipate 2-3 articles on math paradigm and memory data (EEG and performance measures) from the initial study. We expect to recruit half (n=50) of the subjects for the second study. 2-3 abstracts and/or brief reports on physiological (EEG, autonomic measures) and performance (reaction time, response accuracy) data will be submitted. Year 4 (FY 2007): It is expected that subject recruitment for this study will be completed. 2-3 abstracts and brief reports will be submitted. 4.What were the most significant accomplishments this past year? A. Single most significant accomplishment during FY 2004: None. This is a newly established research project that carries forward research begun on project 6251-51000-002-00D. Accomplishments for FY 2004 may be viewed on 6250-51000-002-00D. B. Other significant accomplishments, if any: None. C. Significant activities that support special target populations: None. 5.Describe the major accomplishments over the life of the project, including their predicted or actual impact. None. This is a newly established research project that carries forward research begun on project 6251-51000-002-00D. Accomplishments up to this point may be viewed on 6250-51000-002-00D. 6.What science and/or technologies have been transferred and to whom? When is the science and/or technology likely to become available to the end-user (industry, farmer, other scientists)? What are the constraints, if known, to the adoption and durability of the technology products? None. 7.List your most important publications in the popular press and presentations to organizations and articles written about your work. None.