Where's the Federal Funding for Food Systems Research?

Objectives This research project provides a novel assessment of historic and current levels of federal funding for systems-based nutrition research, defined as research that evaluates nutrition and dietary patterns in the context of agroecological systems, and demonstrates the need for greater public funding by identifying persistent research gaps in food systems research and the social, economic, and environmental costs of these needs remaining unmet. The work is being motivated by a growing movement among nutrition and health advocates to elevate the role of nutrition in improving population health and reducing health care costs and highlight the need for greater public funding for and focus on nutrition research. Methods Federal spending on systems-based nutrition research was estimated using information from the NIH Human Nutrition Research Information Management System and direct communication with federal agencies providing funding for initiatives supporting relevant research between 2010 and 2020. Gaps in systems-based nutrition research will be defined based on systematic evaluation by federal entities such as the 2015 and 2020 Dietary Guidelines Advisory Committees and Interagency Committee on Human Nutrition Research. Results Preliminary results indicate that there is less than $150 million in federal funding allocated to nutrition research related to food and agricultural production, food processing and manufacturing, supply chains, and sustainable diets, representing less than 10% of all annual nutrition research funding, which has remained stagnant for decades. Conclusions Federal investments in systems-based nutrition research at leading federal institutions, including the US Department of Agriculture and National Institutes of Health, pale in comparison to the costs of diet-related disease and threats posed by climate change, environmental pollution, and diet-related health disparities. Greater investments in this field of study, including filling research gaps identified by leading expert reports and improving coordination of research among federal agencies, will be essential to developing effective solutions to pressing public health threats. Funding Sources Funding provided by The Lumpkin Family Foundation, The Martin Foundation, the WK Kellogg Foundation, and the Union of Concerned Scientists members.

USDA, NIH and FDA Iodine Database of U.S. Foods for Estimating Iodine Intakes

Objectives Data on the iodine content of foods are needed to assess intake and plan dietary guidance. Iodine is central for thyroid function in human growth, reproduction, neurologic development and energy metabolism, and inadequate or excessive intakes can cause thyroid dysfunction and/or disease. Overall, U.S. iodine intake is sufficient, but some women of reproductive age and pregnant women may be at risk for deficiency, as well as people whose dietary patterns do not include iodine-rich foods. Methods A Special Interest Database (SID) was developed through the collaboration of the Methods and Application of Food Composition Laboratory (USDA), the Food and Drug Administration (FDA), and the Office of Dietary Supplements (NIH). Data for foods and beverages were derived from samples analyzed by USDA and the FDA Total Diet Study; foods included seaweed, fish and other seafood, dairy, iodized salt, eggs, and commercial foods; metadata were captured as varying iodine levels may arise from feed supplementation, iodophor use, and iodine-containing ingredients in processed foods. Samples were analyzed for iodine using inductively coupled plasma mass spectrometry (ICP-MS). Quality control included certified reference materials and secondary in-house controls. Results The Special Interest Database on Iodine (https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/methods-and-application-of-food-composition-laboratory/mafcl-site-pages/iodine/) was released in 2020 and includes food descriptions, means, standard deviations, value ranges, sample sizes, and supporting information for 430 foods. Foods continue to be analyzed for iodine and added to the database. In addition, iodine intakes of the U.S. population are being calculated by mapping the iodine content of foods to food consumption data from the 2014 U.S. National Health and Nutrition Examination Survey (NHANES) and eventually more recent NHANES dietary data. Conclusions The SID on Iodine and the mapped NHANES data provide needed information to monitor iodine status and develop dietary guidance for the general U.S. population and vulnerable subgroups. Furthermore, the database can provide a valuable tool for other research programs and clinical applications in iodine nutrition. Funding Sources NIH Office of Dietary Supplements.

Perspective: Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity

ABSTRACT In human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.

Perspective: Guidelines Needed for the Conduct of Human Nutrition Randomized Controlled Trials

ABSTRACT Guidelines for designing, conducting, documenting, and reporting human nutrition randomized controlled trials (RCTs) have as yet to be developed and disseminated as reference for investigators, funders, regulators, institutions, assessors, trainees, and others involved in human nutrition research. Diet-related interventions can include diet and/or behavioral manipulation, provision of foods or entire meals, or delivery of dietary components in individual food items or supplements. This Perspective introduces a series of papers that outline core principles for the design and conduct of human nutrition RCTs, documentation and reporting of all aspects of clinical trial management, and data analysis and reporting of results. Human nutrition RCTs have unique considerations delineated in these papers. Conducting them with the highest scientific rigor is essential to the development of evidence-based dietary guidance for promoting optimal health and advancing health care.

Perspective: US Documentation and Regulation of Human Nutrition Randomized Controlled Trials

ABSTRACT Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

Preanalytical Sample Handling Conditions and Their Effects on the Human Serum Metabolome in Epidemiologic Studies

Many epidemiologic studies use metabolomics for discovery-based research. The degree to which sample handling may influence findings, however, is poorly understood. In 2016, serum samples from 13 volunteers from the US Department of Agriculture’s Beltsville Human Nutrition Research Center were subjected to different clotting (30 minutes/120 minutes) and refrigeration (0 minutes/24 hours) conditions, as well as different numbers (0/1/4) and temperatures (ice/refrigerator/room temperature) of thaws. The median absolute percent difference (APD) between metabolite levels and correlations between levels across conditions were estimated for 628 metabolites. The potential for handling artifacts to induce false-positive associations was estimated using variable hypothetical scenarios in which 1%–100% of case samples had different handling than control samples. All handling conditions influenced metabolite levels. Across metabolites, the median APD when extending clotting time was 9.08%. When increasing the number of thaws from 0 to 4, the median APD was 10.05% for ice and 5.54% for room temperature. Metabolite levels were correlated highly across conditions (all r’s ≥ 0.84), indicating that relative ranks were preserved. However, if handling varied even modestly by case status, our hypotheticals showed that results can be biased and can result in false-positive findings. Sample handling affects levels of metabolites, and special care should be taken to minimize effects. Shorter room-temperature thaws should be preferred over longer ice thaws, and handling should be meticulously matched by case status.

Report of a member-led meeting: how stable isotope techniques can enhance human nutrition research

A Nutrition Society member-led meeting was held on 9 January 2020 at The University of Surrey, UK. Sixty people registered for the event, and all were invited to participate, either through chairing a session, presenting a ‘3 min lightning talk’ or by presenting a poster. The meeting consisted of an introduction to the topic by Dr Barbara Fielding, with presentations from eight invited speakers. There were also eight lightning talks and a poster session. The meeting aimed to highlight recent research that has used stable isotope tracer techniques to understand human metabolism. Such studies have irrefutably shaped our current understanding of metabolism and yet remain a mystery to many. The meeting aimed to de-mystify their use in nutrition research.

Trimethylamine-N-Oxide (TMAO) Is Not Associated with Average Daily Intake of Red Meat or TMAO-Precursor Foods in a Generally Healthy Population

Objectives The microbial metabolite trimethylamine n-oxide (TMAO) is associated with cardiovascular and renal disease. The dietary factors contributing to plasma TMAO concentrations are not well characterized in a generally healthy population unmedicated for metabolic diseases. The objective of this study was to assess the relationships among TMAO-precursor foods, TMAO, and classic cardiometabolic markers in a generally healthy population stratified for age, sex, and BMI. Methods Fasting plasma TMAO was quantified using liquid chromatography-mass spectrometry in 356 participants (n = 188 female, 18–65 yr, 18–40 BMI) enrolled in the cross-sectional Nutritional Phenotyping Study conducted as the USDA Western Human Nutrition Center. Diet was assessed by averaging 2 weekday and 1 weekend ASA-24hr recalls cleaned by NCBI guidelines. Fasting plasma analytes such as glucose, insulin, triglycerides, and cholesterol were measured using the Cobas Integra 400 Plus. Variables were transformed to conform to the normal distribution. Regression models assessing health parameters and TMAO were adjusted for age, sex, and the kidney function marker, cystatin C. Models assessing TMAO and diet variables were adjusted for age, sex, and energy intake. Composite variables describing average intake of red meat and TMAO-precursor foods were created by summing the appropriate ASA24 variables. Results TMAO was associated with age (P = 0.001), but not sex or BMI. A significant interaction (P = 0.006) between sex and age was used in all models. Of the variables analyzed, only refined grains and total energy intake were significantly associated with TMAO (r = −0.11, P = 0.04; r = 0.12, P = 0.03, respectively). Reduced renal function as assessed by circulating cystatin C concentrations was associated with plasma TMAO (r = 0.18, P < 0.001). Average daily red meat consumption as well as average daily TMAO-precursor consumption was not significantly associated with TMAO (P = 0.137, P = 0.554, respectively). In contrast, average daily fiber intake was marginally related to TMAO (B = −0.11, SE = 0.01, P = 0.07). Conclusions In this generally healthy population, no relationship between red meat or TMAO-precursor foods and TMAO was identified. Funding Sources The Beef Checkoff (R01HL128572); USDA/ARS/Western Human Nutrition Research Center project funds (2032–51,000-025–00D).