A Decade of Dietary Assessment Methodology Research at the National Institutes of Health, 2012-2021.

BACKGROUND: Assessment of individual and population-level dietary intake is critical for public health surveillance, epidemiology, and dietary intervention research. In recognition of that need, the National Insitutes of Health (NIH) has a history of funding research projects designed to support the development, implementation, and refinement of tools to assess dietary intake in humans. OBJECTIVES: This report provides data and information on NIH-funded dietary intake assessment methodological research over the period of 2012-2021. METHODS: Data were extracted from an internal NIH data system using the Research, Condition, and Disease Categorization (RCDC) spending category for Nutrition. Data were then examined to identify research focused on dietary assessment tools or methods to capture or analyze dietary intake. RESULTS: Over the decade of 2012-2021, NIH supported 46 grants and 2 large contracts specific to dietary assessment methods development. The top 6 Institutes and Offices funding dietary assessment methods research were identified. Most projects were limited to adults. Projects ranged from novel methods to capture dietary intake, and refinement of analytical methods, to biomarkers of dietary intake. One key contract supported the automated self-administered 24-h dietary assessment tool (ASA24), a widely used, free tool available to the research community for assessing dietary intake. CONCLUSIONS: NIH's support for dietary assessment methods development over this 10-y period was small but grew over time with an expanding number and variety of methods, data sources, and technological advancements in the assessment of dietary intake. NIH remains committed to supporting research seeking to advance the field of dietary assessment methods research.

Diet and Physical Activity Prevention Research Supported by the U.S. NIH From 2012-2017.

INTRODUCTION: Poor diet and inadequate physical activity are common contributors to preventable death in the U.S. This paper provides a summary of the NIH-sponsored research on disease prevention that underlies public health and clinical recommendations to improve diet and physical activity. METHODS: A representative sample (n=11,082) of research grants and cooperative agreements (research projects) representing the NIH prevention research portfolio between 2012 and 2017 were hand coded by trained analysts in 2017-2018. This manuscript describes the rationale(s), exposure(s), outcome(s), population(s), and study design(s) in prevention research focused on diet and physical activity and compares this research to identified research gaps in the field. RESULTS: A relatively stable 7.8% (95% CI=7.0%, 8.8%) and 5.0% (95% CI=4.4%, 5.7%) of the NIH prevention research projects were focused on diet and physical activity, respectively, during 2012-2017. These projects often explored diet and physical activity together in the context of obesity, included observational studies, and focused on a general adult population. Few of these projects focused on development of improved assessment methods. Approximately 50% of these studies were related to research gaps identified by the 2015 Dietary or 2018 Physical Activity Guidelines Advisory Committee Scientific Reports. CONCLUSIONS: Opportunities exist for more engagement by NIH and scientific investigators in diet- and physical activity-focused prevention research, particularly around assessment and known research gaps.

Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.

Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of effects on reproduction and development to inform clinical development and labeling. General study designs in regulatory guidances do not specifically mandate use of pathology or reproductive end points across all study types; thus, inclusion and use of these end points are variable. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) formed a Working Group to assess the current guidelines and practices on the use of reproductive, anatomic pathology, and clinical pathology end points in general, reproductive, and developmental toxicology studies. The Working Group constructed a survey sent to pathologists and reproductive toxicologists, and responses from participating organizations were collected through the STP for evaluation by the Working Group. The regulatory context, relevant survey results, and collective experience of the Working Group are discussed and provide the basis of each assessment by study type. Overall, the current practice of including specific end points on a case-by-case basis is considered appropriate. Points to consider are summarized for inclusion of reproductive end points in general toxicity studies and for the informed use of pathology end points in reproductive and developmental toxicity studies.

Dietary supplement research portfolio at the NIH, 2009-2011.

The U.S. dietary supplement market increased by 7.5% in 2012 compared with 2011, reaching $32.5 billion in sales. Therefore, federally supported research on dietary supplements is important to determine their health effects, safety, and efficacy. A portfolio analysis was performed across the NIH and the Office of Dietary Supplements (ODS) for fiscal years (FYs) 2009-2011 by using the databases Human Nutrition Research Information Management (HNRIM) and Computer Access to Research on Dietary Supplements (CARDS). The results indicated that total NIH dietary supplement-related funding for FYs 2009-2011 was $855 million ($295 million in 2009, $311 million in 2010, and $249 million in 2011). The institutes and centers with the highest investment in dietary supplement research were as follows: the National Heart, Lung, and Blood Institute ($135 million); the National Cancer Institute ($188 million); the National Center for Complementary and Alternative Medicine ($99 million); the National Institute of Diabetes and Digestive and Kidney Diseases ($68 million); the National Institute of Environmental Health Sciences ($58 million); and the ODS ($32 million). The dietary supplement ingredients receiving the most funding were botanicals (22%), vitamins (20%), lipids (14%), and minerals and trace elements (10%). The top 3 outcome research areas were cancer (61% of total dietary supplement investment), cardiovascular disease (47%), and women's reproductive health (38%). In FYs 2009, 2010, and 2011, the ODS provided 3.5%, 3.6%, and 4.1%, respectively, of the NIH investment in dietary supplement research. ODS funding focused on cellular, enzymatic, or molecular mechanisms (64% of total ODS funding). This portfolio analysis demonstrates that the NIH has committed substantial funding to dietary supplement research in an effort to expand the scientific knowledge base on the efficacy and safety of dietary supplements.

NIH and USDA funding of dietary supplement research, 1999-2007.

Over one-half of U.S. adults use dietary supplements, so federally supported research into the safety and effectiveness of these compounds is important for the health of many Americans. Data collected in the Computer Access to Research on Dietary Supplements database, which compiles federally sponsored dietary supplement-related research, are useful to scientists in determining the type of dietary supplement research that federal agencies are currently funding and where research gaps exist. This article describes the dietary supplement-related research funded by the NIH and the USDA. Between fiscal years 1999 and 2007, the number of research projects and funding for dietary supplement research more than doubled. During that period, NIH funded 6748 dietary supplement-related projects at a cost of $1.9 billion and the USDA funded 2258 projects at a cost of $347 million. The top funded dietary supplement ingredient categories were vitamins and minerals, botanicals, phytochemicals, and fatty acids. Cancer was by far the most frequent health outcome in dietary supplement research funding, nearly double the next closest health outcome category. Other health outcomes with the greatest funding were cellular and molecular mechanisms, cardiovascular health, women's reproductive health, and immune function. The greatest number of dietary supplement research projects are funded by the NIH National Cancer Institute, the NIH National Center for Complementary and Alternative Medicine, the NIH Office of Dietary Supplements, and the USDA Agricultural Research Service.

Computer access to research on dietary supplements: a database of federally funded dietary supplement research.

Dietary supplement use is prevalent in the United States, but support for supplement research has been relatively modest and only recently emphasized at the NIH. The Dietary Supplement Health and Education Act of 1994 led to the creation of the Office of Dietary Supplements (ODS) at the NIH to promote research on dietary supplements. In order to track federally funded dietary supplement research, the ODS developed a database known as Computer Access to Research on Dietary Supplements (CARDS). This article provides an overview of the development and potential uses of the CARDS database. In addition, we report that NIH-funded dietary supplement research steadily increased from fiscal year (FY) 1999 through 2002. The majority of NIH institutes or centers (ICs) funded research relevant to dietary supplements during this time, led by the National Cancer Institute and one of the newest NIH ICs, the National Center for Complementary and Alternative Medicine. CARDS data indicate that NIH-funded dietary supplement research from FY 1999 through 2002 involved primarily vitamins, minerals, botanicals and phytochemicals. Cancer and cardiovascular disease, two of the leading causes of morbidity and mortality in the United States, collectively accounted for almost 45% of the research related to dietary supplements. A variety of types of research studies were funded, with the majority consisting of human intervention studies. This information is useful to evaluate trends in federally funded dietary supplement research, identify research gaps, and help research scientists identify potential sources of NIH funding.