Developmental Process and Early Phases of Implementation for the US Interagency Committee on Human Nutrition Research National Nutrition Research Roadmap 2016-2021.

The Interagency Committee on Human Nutrition Research (ICHNR) is charged with improving the planning, coordination, and communication among federal agencies engaged in nutrition research and with facilitating the development and updating of plans for federal research programs to meet current and future domestic and international needs for nutrition. The ICHNR is co-chaired by the USDA Under Secretary for Research, Education, and Economics and Chief Scientist and the US Department of Health and Human Services Assistant Secretary for Health and is made up of >10 departments and agencies. Once the ICHNR was reassembled after a 10-y hiatus, the ICHNR recognized a need for a written roadmap to identify critical human nutrition research gaps and opportunities. This commentary provides an overview of the process the ICHNR undertook to develop a first-of-its-kind National Nutrition Research Roadmap, which was publicly released on 4 March 2016. The primary audience for the Roadmap is federal science agency leaders, along with relevant program and policy staff who rely on federally supported human nutrition research, in addition to the broader scientific community. The Roadmap is framed around the following 3 questions: 1) How can we better understand and define eating patterns to improve and sustain health? 2) What can be done to help people choose healthy eating patterns? 3) How can we develop and engage innovative methods and systems to accelerate discoveries in human nutrition? Within these 3 questions, 11 topical areas were identified on the basis of the following criteria: population impact, feasibility given current technological capacities, and emerging scientific opportunities. This commentary highlights initial federal and some professional research society efforts to address the Roadmap's research and resource priorities. We conclude by noting examples of early collaborations and partnerships to move human nutrition research forward in the 21st century.

Guidance from an NIH workshop on designing, implementing, and reporting clinical studies of soy interventions.

The NIH sponsored a scientific workshop, "Soy Protein/Isoflavone Research: Challenges in Designing and Evaluating Intervention Studies," July 28-29, 2009. The workshop goal was to provide guidance for the next generation of soy protein/isoflavone human research. Session topics included population exposure to soy; the variability of the human response to soy; product composition; methods, tools, and resources available to estimate exposure and protocol adherence; and analytical methods to assess soy in foods and supplements and analytes in biologic fluids and other tissues. The intent of the workshop was to address the quality of soy studies, not the efficacy or safety of soy. Prior NIH workshops and an evidence-based review questioned the quality of data from human soy studies. If clinical studies are pursued, investigators need to ensure that the experimental designs are optimal and the studies properly executed. The workshop participants identified methodological issues that may confound study results and interpretation. Scientifically sound and useful options for dealing with these issues were discussed. The resulting guidance is presented in this document with a brief rationale. The guidance is specific to soy clinical research and does not address nonsoy-related factors that should also be considered in designing and reporting clinical studies. This guidance may be used by investigators, journal editors, study sponsors, and protocol reviewers for a variety of purposes, including designing and implementing trials, reporting results, and interpreting published epidemiological and clinical studies.

Dietary reference intakes for vitamin D: justification for a review of the 1997 values.

Recent Institute of Medicine (IOM) reviews of the process for deriving Dietary Reference Intakes (DRIs) suggest that determining the need for a new nutrient review should be evaluated against criteria set a priori. After selecting the criterion of significant new and relevant research, a working group of US and Canadian government scientists used results from a systematic review and 2 conferences on vitamin D and health to evaluate whether significant new and relevant scientific evidence had become available since the 1997 IOM publication of the DRIs for vitamin D. This working group concluded that there appears to be new research meeting the criteria for 4 key DRI questions. The new research is of larger quantity and quality for the elderly than for other groups, but overall 1) adds to the bone-related and status evidence available to the 1997 DRI Committee for several of the life-stage groups, 2) identifies new outcomes with respect to risk of falls and performance measures in the elderly and potential adverse effects, and 3) provides additional information on dose-response relations between intakes and circulating 25-hydroxyvitamin D concentrations and between 25-hydroxyvitamin D concentrations and several health outcomes (ie, bone-related outcomes for all ages and risk of falls and performance measures in older adults). Members of the working group concluded that significant new and relevant research was available for reviewing the existing DRIs for vitamin D while leaving the decision of whether the new research will result in changes to the current DRIs to a future IOM-convened DRI committee.