Dietary and Complementary Feeding Practices of US Infants, 6 to 12 Months: A Narrative Review of the Federal Nutrition Monitoring Data.

Complementary foods and beverages (CFBs) are key components of an infant's diet in the second 6 months of life. This article summarizes nutrition and feeding practices examined by the 2020 Dietary Guidelines Advisory Committees during the CFB life stage. Breastfeeding initiation is high (84%), but exclusive breastfeeding at 6 months (26%) is below the Healthy People 2030 goal (42%). Most infants (51%) are introduced to CFBs sometime before 6 months. The primary mode of feeding (ie, human milk fed [HMF]; infant formula or mixed formula and human milk fed [FMF]) at the initiation of CFBs is associated with the timing of introduction and types of CFBs reported. FMF infants (42%) are more likely to be introduced to CFBs before 4 months compared with HMF infants (19%). Different dietary patterns, such as higher prevalence of consumption and mean amounts, were observed, including fruit, grains, dairy, proteins, and solid fats. Compared with HMF infants of the same age, FMF infants consume more total energy (845 vs 631 kcal) and protein (22 vs 12 g) from all sources, and more energy (345 vs 204 kcal) and protein (11 vs 6 g) from CFBs alone. HMF infants have a higher prevalence of risk of inadequate intakes of iron (77% vs 7%), zinc (54% vs <3%), and protein (27% vs <3%). FMF infants are more likely to have an early introduction (<12 months) to fruit juice (45% vs 20%) and cow's milk (36% vs 24%). Registered dietitian nutritionists and nutritional professionals should consider tailoring their advice to caregivers on dietary and complementary feeding practices, taking into account the primary mode of milk feeding during this life stage to support infants' nutrient adequacy. National studies that address the limitations of this analysis, including small sample sizes and imputed breast milk volume, could refine findings from this analysis.

Development of Food Pattern Recommendations for Infants and Toddlers 6-24 Months of Age to Support the Dietary Guidelines for Americans, 2020-2025.

BACKGROUND: Developing food-based dietary guidelines (FBDGs) for infants and toddlers is a complex task that few countries have attempted. OBJECTIVES: Our objectives are to describe the process of food pattern modeling (FPM) conducted to develop FBDGs for the Dietary Guidelines for Americans, 2020-2025 for infants 6 to <12 mo and toddlers 12 to <24 mo of age, as well as the implications of the results and areas needing further work. METHODS: The US 2020 Dietary Guidelines Advisory Committee, with the support of federal staff, conducted FPM analyses using 5 steps: 1) identified energy intake targets; 2) established nutritional goals; 3) identified food groupings and expected amounts, using 3 options for the amount of energy from human milk in each age interval; 4) estimated expected nutrient intakes for each scenario, based on nutrient-dense representative foods; and 5) evaluated expected nutrient intakes against nutritional goals. RESULTS: For human milk-fed infants (and toddlers), example combinations of complementary foods and beverages were developed that come close to meeting almost all nutrient recommendations if iron-fortified infant cereals are included at 6 to <12 mo of age. These combinations would also be suitable for formula-fed infants. For toddlers not fed human milk, 2 patterns were developed: the Healthy US-Style Pattern and the Healthy Vegetarian Pattern (a lacto-ovo vegetarian pattern). Achieving nutrient recommendations left virtually no remaining energy for added sugars. CONCLUSIONS: It is challenging to meet all nutrient needs during these age intervals. Added sugars should be avoided for infants and toddlers <2 y of age. Further work is needed to 1) establish a reference human milk composition profile, 2) update and strengthen the DRI values for these age groups, and 3) use optimization modeling, in combination with FPM, to identify combinations of foods that meet all nutritional goals.

Perspective: Framework for Developing Recommended Intakes of Bioactive Dietary Substances.

Dietary bioactives are food substances that promote health but are not essential to prevent typical deficiency conditions. Examples include lutein and zeaxanthin, omega-3 fatty acids, and flavonoids. When quality evidence is available, quantified intake recommendations linking dietary bioactives with specific health benefits will enable health professionals to provide evidence-based information to consumers. Without evidence-based recommendations, consumers use information from available sources that often lack standards and rigor. This article describes a framework to develop guidance based on quality evidence fully vetted for efficacy and safety by qualified experts, and designed to communicate the amounts of specific dietary bioactive compounds with identified health benefits. The 4-step Framework described here can be adapted by credible health organizations to work within their guideline development process. Standards of practice used in clinical guidelines are adapted to quantify dietary bioactive intake recommendations from foods consumed by the general public, by taking into account that side effects and trade-offs are often needed for medical treatments but are not acceptable for dietary bioactives. In quantifying dietary bioactive recommendations, this Framework establishes 4 decision-making steps: 1) characterize the bioactive, determine amounts in specific food sources, and quantify intakes; 2) evaluate safety; 3) quantify the causal relation between the specific bioactive and accepted markers of health or normal function via systematic evidence reviews; and 4) translate the evidence into a quantified bioactive intake statement. This Framework provides a working model that can be updated as new approaches are advanced.

A Proposed Framework for Identifying Nutrients and Food Components of Public Health Relevance in the Dietary Guidelines for Americans.

BACKGROUND: Identification of nutrients of public health concern has been a hallmark of the Dietary Guidelines for Americans (DGA); however, a formal systematic process for identifying them has not been published. OBJECTIVES: We aimed to propose a framework for identifying "nutrients or food components" (NFCs) of public health relevance to inform the DGA. METHODS: The proposed framework consists of 1) defining terminology; 2) establishing quantitative thresholds to identify NFCs; and 3) examining national data. The proposed framework utilizes available data from 3 key data sources or "prongs": 1) dietary intakes; 2) biological endpoints; and 3) clinical health consequences such as prevalence of health conditions, directly or indirectly through validated surrogate markers. RESULTS: In identifying potential NFCs of public health concern, the 2020 DGA Committee developed a decision-tree framework with suggestions for combining the 3 prongs. The identified NFCs of public health concern for Americans ≥1 y old included fiber, calcium (≥2 y old), vitamin D, and potassium for low intakes and sodium, added sugars, and saturated fats (≥2 y old) for high intakes that were associated with adverse health consequences. Iron was identified among infants ages 6-12 mo fed human milk. For reproductive-aged and pregnant females, iron (all trimesters) and folate (first trimester) were identified for low intake, based on dietary and biomarker data (iron) or the severity of the consequence (folic acid and neural tube defects). Among pregnant women, low iodine was of potential public health concern based on biomarker data. Other NFCs that were underconsumed, overconsumed, and pose special challenges were identified across the life course. CONCLUSIONS: The proposed decision-tree framework was intended to streamline and add transparency to the work of this and future Dietary Guidelines Advisory Committees to identify NFCs that need to be encouraged or discouraged in order to help reduce risk of chronic disease and promote health and energy balance in the population.

Perspective: Impact of the National Academy of Sciences, Engineering, and Medicine Report on the Process for the 2020 Dietary Guidelines Advisory Committee.

The National Academy of Sciences, Engineering, and Medicine (NASEM) recommended steps to redesign the process of developing the Dietary Guidelines for Americans (DGA) are based on 5 guiding principles (enhance transparency; promote diversity of expertise and experience; support a deliberative process; manage biases and conflicts of interest; and adopt state-of-the-art processes and methods). Using these principles and recommendations, the USDA and HHS updated the process for developing the 2020-2025 Dietary Guidelines, including the process for appointing members and managing the work of the 2020 Dietary Guidelines Advisory Committee. Modifications included having public comment on the topics and questions to be addressed by the Federal Advisory Committee, reviewing professional and financial activities on potential appointees to the committee prior to their appointment, redesigning the website to provide status updates on the work of the committee as analytical frameworks and draft conclusions were developed, strengthening the approaches for conducting systematic reviews, and adding a public meeting for discussion of the final report before its submission to the Secretaries of the USDA and HHS. Because the DGA is reviewed and updated every 5 y, it is possible to learn from each cycle what works well and where improvements in the process can be implemented. The current article illustrates, from the perspective of the advisory committee, the impact of the NASEM report on the development of the scientific report by examining changes in the process consistent with the 5 principles.

Medical Foods: Science, Regulation, and Practical Aspects. Summary of a Workshop.

On August 13-14, 2019, the Healthcare Nutrition Council and the ASN held the Medical Foods Workshop: Science, Regulation, and Practical Aspects. Medical food products help patients manage their disease and improve their quality of life. Yet many hurdles exist to getting patients new products. In this workshop, participants addressed some of these hurdles, with specific emphasis on topics like the statutory term distinctive nutritional requirements, the regulatory term modification of the diet alone, the role of clinical guidelines, the requirement that medical foods be used under medical supervision, and differentiation of foods for special dietary use from medical foods, as well as product innovation and future research. Real-world examples were discussed for intractable epilepsy, diabetes, end-stage renal disease, and inflammatory bowel disease.

Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes.

Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products. Design, Setting, and Participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.

Establishing What Constitutes a Healthy Human Gut Microbiome: State of the Science, Regulatory Considerations, and Future Directions.

On December 17, 2018, the North American branch of the International Life Sciences Institute (ILSI North America) convened a workshop "Can We Begin to Define a Healthy Gut Microbiome Through Quantifiable Characteristics?" with >40 invited academic, government, and industry experts in Washington, DC. The workshop objectives were to 1) develop a collective expert assessment of the state of the evidence on the human gut microbiome and associated human health benefits, 2) see if there was sufficient evidence to establish measurable gut microbiome characteristics that could serve as indicators of "health," 3) identify short- and long-term research needs to fully characterize healthy gut microbiome-host relationships, and 4) publish the findings. Conclusions were as follows: 1) mechanistic links of specific changes in gut microbiome structure with function or markers of human health are not yet established; 2) it is not established if dysbiosis is a cause, consequence, or both of changes in human gut epithelial function and disease; 3) microbiome communities are highly individualized, show a high degree of interindividual variation to perturbation, and tend to be stable over years; 4) the complexity of microbiome-host interactions requires a comprehensive, multidisciplinary research agenda to elucidate relationships between gut microbiome and host health; 5) biomarkers and/or surrogate indicators of host function and pathogenic processes based on the microbiome need to be determined and validated, along with normal ranges, using approaches similar to those used to establish biomarkers and/or surrogate indicators based on host metabolic phenotypes; 6) future studies measuring responses to an exposure or intervention need to combine validated microbiome-related biomarkers and/or surrogate indicators with multiomics characterization of the microbiome; and 7) because static genetic sampling misses important short- and long-term microbiome-related dynamic changes to host health, future studies must be powered to account for inter- and intraindividual variation and should use repeated measures within individuals.

Considerations for best practices in studies of fiber or other dietary components and the intestinal microbiome.

A 2-day workshop organized by the National Institutes of Health and U.S. Department of Agriculture included 16 presentations focused on the role of diet in alterations of the gastrointestinal microbiome, primarily that of the colon. Although thousands of research projects have been funded by U.S. federal agencies to study the intestinal microbiome of humans and a variety of animal models, only a minority addresses dietary effects, and a small subset is described in sufficient detail to allow reproduction of a study. Whereas there are standards being developed for many aspects of microbiome studies, such as sample collection, nucleic acid extraction, data handling, etc., none has been proposed for the dietary component; thus this workshop focused on the latter specific point. It is important to foster rigor in design and reproducibility of published studies to maintain high quality and enable designs that can be compared in systematic reviews. Speakers addressed the influence of the structure of the fermentable carbohydrate on the microbiota and the variables to consider in design of studies using animals, in vitro models, and human subjects. For all types of studies, strengths and weaknesses of various designs were highlighted, and for human studies, comparisons between controlled feeding and observational designs were discussed. Because of the lack of published, best-diet formulations for specific research questions, the main recommendation is to describe dietary ingredients and treatments in as much detail as possible to allow reproduction by other scientists.

Scientific rigor and credibility in the nutrition research landscape.

Scientific progress depends on the quality and credibility of research methods. As discourse on rigor, transparency, and reproducibility joins the cacophony of nutrition information and misinformation in mass media, buttressing the real and perceived reliability of nutrition science is more important than ever. This broad topic was the focus of a 2016 plenary session, "Scientific Rigor and Competing Interests in the Nutrition Research Landscape." This article summarizes and expands on this session in an effort to increase understanding and dialogue with regard to factors that limit the real and perceived reliability of nutrition science and steps that can be taken to mitigate those factors. The end goal is to both earn and merit greater trust in nutrition science by both the scientific community and the general public. The authors offer suggestions in each of the domains of education and training, communications, research conduct, and procedures and policies to help achieve this goal. The authors emphasize the need for adequate funding to support these efforts toward greater rigor and transparency, which will be resource demanding and may require either increased research funding or the recognition that a greater proportion of research funding may need to be allocated to these tasks.

Research Priorities for Studies Linking Intake of Low-Calorie Sweeteners and Potentially Related Health Outcomes: Research Methodology and Study Design.

Background: In a world of finite research funding, efforts to prioritize future research topics are increasingly necessary. Objective: The aim of this study was to identify and prioritize the direction of future research in the broad area of low-calorie sweetener (LCS) intake and potentially related health outcomes by using a novel method that incorporates evidence mapping in the Agency for Healthcare Research and Quality's Future Research Needs (FRN) process. Methods: A diverse expert stakeholder panel was convened and engaged to identify research gaps and prioritize future research needs. An independent research team hosted a number of interactive webinars and elicited feedback through surveys and individual interviews with the stakeholder panel, which included policymakers, lay audience members, health providers, a research funder, individuals with food industry experience, and researchers of several different specialties. Results: The stakeholder panel generated and ranked a list of 18 FRN questions across 5 broad research areas. Overall, stakeholder panel members unanimously agreed that the research questions that will have the largest public health impact are those that address outcomes related to body weight, appetite, and dietary intake. Although the LCSs included in this FRN project have all been Generally Recognized as Safe by the FDA or approved as food additives, the recurrent concerns and confusions with regard to the "safety" of LCSs by consumers underscore the importance of communicating the science to the general public. Conclusion: Our project provides evidence that engaging a diverse expert stakeholder panel is an effective method of translating gaps in nutrition research into prioritized areas of future research.

Postprandial Metabolism of Macronutrients and Cardiometabolic Risk: Recent Developments, Emerging Concepts, and Future Directions.

Cardiovascular disease (CVD) is the leading cause of death in the United States. Although the role of habitual lifestyle factors such as physical activity and dietary patterns in increasing CVD risk has long been appreciated, less is known about how acute daily activities may cumulatively contribute to long-term disease risk. Here, the term acute refers to metabolic responses occurring in a short period of time after eating, and the goal of this article is to review recently identified stressors that can occur after meals and during the sleep-wake cycle to affect macronutrient metabolism. It is hypothesized that these events, when repeated on a regular basis, contribute to the observed long-term behavioral risks identified in population studies. In this regard, developments in research methods have supported key advancements in 3 fields of macronutrient metabolism. The first of these research areas is the focus on the immediate postmeal metabolism, spanning from early intestinal adsorptive events to the impact of incretin hormones on these events. The second topic is a focus on the importance of meal components on postprandial vasculature function. Finally, some of the most exciting advances are being made in understanding dysregulation in metabolism early in the day, due to insufficient sleep, that may affect subsequent processing of nutrients throughout the day. Key future research questions are highlighted which will lead to a better understanding of the relations between nocturnal, basal (fasting), and early postmeal events, and aid in the development of optimal sleep and targeted dietary patterns to reduce cardiometabolic risk.

Science-based regulatory and policy considerations in nutrition.

Scientific evidence is necessary for the development of effective and enforceable regulations and government policy. To use scientific information appropriately, a systematic approach is needed for review and evaluation of the evidence. Federal agencies in the United States have developed useful approaches for such a review and evaluation to develop nutrition labeling, including health claims, and for updating of the Dietary Guidelines for Americans. The WHO is using a systematic evaluation process to update its recommendations on diet and health. The results of such reviews also highlight research needs to address relevant gaps in our knowledge.

Mushrooms and Health Summit proceedings.

The Mushroom Council convened the Mushrooms and Health Summit in Washington, DC, on 9-10 September 2013. The proceedings are synthesized in this article. Although mushrooms have long been regarded as health-promoting foods, research specific to their role in a healthful diet and in health promotion has advanced in the past decade. The earliest mushroom cultivation was documented in China, which remains among the top global mushroom producers, along with the United States, Italy, The Netherlands, and Poland. Although considered a vegetable in dietary advice, mushrooms are fungi, set apart by vitamin B-12 in very low quantity but in the same form found in meat, ergosterol converted with UV light to vitamin D2, and conjugated linoleic acid. Mushrooms are a rare source of ergothioneine as well as selenium, fiber, and several other vitamins and minerals. Some preclinical and clinical studies suggest impacts of mushrooms on cognition, weight management, oral health, and cancer risk. Preliminary evidence suggests that mushrooms may support healthy immune and inflammatory responses through interaction with the gut microbiota, enhancing development of adaptive immunity, and improved immune cell functionality. In addition to imparting direct nutritional and health benefits, analysis of U.S. food intake survey data reveals that mushrooms are associated with higher dietary quality. Also, early sensory research suggests that mushrooms blended with meats and lower sodium dishes are well liked and may help to reduce intakes of red meat and salt without compromising taste. As research progresses on the specific health effects of mushrooms, there is a need for effective communication efforts to leverage mushrooms to improve overall dietary quality.

Strategies to optimize the impact of nutritional surveys and epidemiological studies.

The development of nutrition and health guidelines and policies requires reliable scientific information. Unfortunately, theoretical considerations and empirical evidence indicate that a large percentage of science-based claims rely on studies that fail to replicate. The session "Strategies to Optimize the Impact of Nutrition Surveys and Epidemiological Studies" focused on the elements of design, interpretation, and communication of nutritional surveys and epidemiological studies to enhance and encourage the production of reliable, objective evidence for use in developing dietary guidance for the public. The speakers called for more transparency of research, raw data, consistent data-staging techniques, and improved data analysis. New approaches to collecting data are urgently needed to increase the credibility and utility of findings from nutrition epidemiological studies. Such studies are critical for furthering our knowledge and understanding of the effects of diet on health.

FDA's review of scientific evidence for health claims.

Under the Federal Food, Drug, and Cosmetic Act health claims on foods or dietary supplements must be authorized by the FDA. Health claims describe the relationship between a food, food component, or dietary supplement and reducing the risk of a disease or health-related condition. Under interim guidance and enforcement discretion, certain qualified health claims have been provided for on foods and dietary supplements; these claims contain language to qualify the quality and strength of scientific evidence to support the claim because they are not based on significant scientific agreement, which is the standard for health claims authorized by the Federal Food, Drug, and Cosmetic Act. In order to meet its statutory responsibility for evaluation of health claims, the agency has developed guidelines for review of scientific evidence in support of a health claim.