New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition Research

New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition Research is sponsored by National Institutes of Health (NIH). Encourages the development of new methodologies for dietary supplement and nutrition research.

New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition research | Grants & Funding U.S. Department of Health and Human Services National Institutes of Health New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition research When beginning your next investigator-initiated application, consider the following NIH highlighted topic.

The area of science described below is of interest to the listed NIH Institutes, Centers, and Offices (ICOs). This is not a notice of funding opportunity (NOFO). Apply through an appropriate NIH Parent Funding Announcement or another broad NIH opportunity available on Grants.

gov . Learn how to interpret and use Highlighted Topics . Expiration Date: May 20, 2028 Research on diet-related health outcomes and food safety often relies on animal studies and population-level endpoints and/or is focused on individual dietary components.

However, translational limitations of these approaches can include limited relevance to human biology, metabolism, and dietary exposure patterns; poor sensitivity for detecting subtle, chronic, or life-stage-specific effects; and inability to assess complex foods, novel ingredients, or processing or matrix effects.

As such, the development and validation of methods that are more human-relevant and appropriate for investigating dietary intake and modern food system health effects are urgently needed.

This topic encourages innovative research on human-relevant new approach methodologies (NAMs) (e.g., organoids, tissue chips, microphysiological systems, multi-omics technologies, computational models) to evaluate the safety and efficacy of foods, food components, and dietary supplements for health optimization and chronic disease risk reduction across the lifespan.

Objectives include developing and validating human-based NAMs to: Investigate absorption/distribution/metabolic processes involved in dietary intake of nutrients or non-nutrient bioactive compounds across multiple physiological systems Simulate/predict health outcome relevant interactions between cellular, organ, and body systems in response to complex food or dietary supplement matrices High priority research areas include (but are not limited to) studies that: Identify and validate nutrient or non-nutrient bioactive compound (e.g., botanical phytochemicals, additives) exposure/status biomarkers that are relevant to human health and chronic disease Generate replicable, interoperable datasets on nutrient or bioactive compound absorption and/or metabolism in the context of different (genetics, sex, age, underlying health condition) populations Quantify bioaccessibility (amount of substance released from a food/supplement matrix) or bioavailability (amount of substance absorbed and available to organs/microbiota) of nutrients or bioactive compounds, especially in the context of multi-ingredient dietary supplements or processed foods Assess interactions between food- and dietary supplement-induced cellular/tissue/organ functional modifications (e.g., gene expression, metabolomics, proteomics, nutrient absorption, immune signaling) to improve predictions for whole-person health outcomes Investigate mechanisms of action or biological signatures across complex physiological systems in response to multi-ingredient food interventions and dietary supplement exposure Characterize dietary bioactive substances’ impact on key developmental processes (e.g., neurodevelopment, immune system maturation) to assess potential risks associated with fetal and early childhood exposure This topic is being issued as part of the Make America Healthy Again initiative, which is expanding NIH and agency research into specific areas.

New Approach Methodologies (NAMs) : The expanded use of NAMs can enable earlier, more predictive insights into chronic disease mechanisms using human-relevant models such as organoids, computational simulations, and real-world data integration. This improves prevention, diagnosis, and personalized treatment strategies while reducing reliance on animal studies that often fail to replicate complex human conditions.

The Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and NIH have all committed to using NAMs moving forward, when appropriate.

Central Scientific Contact: Office of Dietary Supplements (ODS) ODS is interested in advancing research in all the objectives and example areas of this topic, with a particular focus on: Simulating or predicting the health effects of dietary supplements in complex biological human systems, disease pathways, and drug interactions Development and validation studies on NAMs focused on improving reproducibility and translatability of dietary supplement safety and efficacy research Development of computational models capable of simulating longitudinal exposure to bioactive substances and studying the cumulative impact of multiple dietary constituents acting on a molecular target over time Multi-system data integration and model validation studies that enhance hypothesis generation and refinement Multidisciplinary research across a variety of fields, including nutrition, dietary supplements, analytical chemistry, toxicology, pharmacology, and food science is encouraged.

IC may give special consideration to support meritorious applications in this topic area. This office does not award grants. Applications must be relevant to the objectives of at least one of the participating Institutes or Centers listed in this topic.

National Center for Complementary and Integrative Health (NCCIH) National Cancer Institute (NCI) NCI research objectives relevant to this topic include, but are not limited to: • Studies assessing human absorption/distribution/metabolism in different cancer risk states and environmental settings • Studies assessing dietary supplement bioavailability in average- and high-risk cancer models for cancer prevention or cancer interception • Studies assessing physiological preferences for different dietary ingredient forms in modifying cancer risk • Studies on interactions between dietary supplements and whole foods assessing functional changes in metabolically normal average-risk individuals vs. high-risk individuals for cancer • Studies assessing novel food ingredients, food processing, food matrix, or dietary components impacting human cancer risks • Studies assessing dietary intervention and cancer therapy interactions • Studies to evaluate intermediate endpoints of dietary interventions NCI may give special consideration to support meritorious applications in this topic area Nancy J.

Emenaker, PhD, MEd, RDN, LD, FAND National Eye Institute (NEI) Nutritional status strongly influences ocular health, and dietary supplements may help mitigate vision loss from diseases such as age-related macular degeneration, diabetic retinopathy, glaucoma, and retinopathy of prematurity. NEI encourages interdisciplinary research that involves NAMs to define how nutrition and metabolism affect eye health and improve vision outcomes.

Areas of interest include, but are not limited to: Interactions of nutritional status with risk, pathogenesis, and progression of eye diseases Nutrient-linked biomarkers predicting susceptibility or resistance to ocular disease that integrates multi-omics technologies Cellular and molecular mechanisms of nutrient-dependent protective pathways in ocular cell types Synergistic, multicomponent formulations to evaluate bioaccessibility, bioavailability, and efficacy that slow, prevent, or reverse vision loss Variability in metabolic responses to nutritional factors using human-based cell, tissue, and organ systems Tiffany Cook, PhD (Retinal Disease) Lisa Neuhold, PhD (Cell and Molecular Technologies, Photoreceptor/RPE Biology) Hongman Song, PhD (Glaucoma) National Institute on Aging (NIA) NIA supports research using human-relevant new approach methodologies (NAMs) to advance understanding of dietary supplements, foods, and nutrition across the aging spectrum, including: Developing and validating NAMs that capture age-related changes in absorption, distribution, metabolism, and physiological responses to nutrients and non-nutrient bioactive compounds Using NAMs to examine multimorbidity, polypharmacy, altered nutrient requirements, and malnutrition risk in older adults Investigating nutrition-related exposures and the hallmarks of aging, including cellular, mitochondrial and immune senescence and host-microbial interactions Applying NAMs to improve prediction of functional, cognitive, and resilience-related outcomes, and to identify aging-relevant biomarkers Evaluating heterogeneity in responses by age, sex, health status, and life-course stage to inform strategies for promoting healthspan and reducing risk of aging-related diseases National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NIDDK is seeking research that develops or validates human NAMs systems to model diet (nutrition)-related chronic diseases with the scope of NIDDK’s research mission.

The purpose is to be able to better predict disease processes, drug efficacy, pathophysiology or genetic modification, and to validate, replace, or complement animal testing. Focus areas include but are not limited to obesity, diabetes, and cystic fibrosis, along with diet related liver-, pancreatic-, endocrine-, gut (GI)-, kidney-, urological- and hematological diseases.

Examples include human organoids, microphysiological systems, or data mining simulations based on human data. Projects of interest could include NAMs that can model the integrative human physiology between tissues within an organ (e.g. GI epithelium and immune tissue) or between organs (e.g., diet x gut-brain communication or diet and gut-microbiome physiology).

IC may give special consideration to support meritorious applications in this topic area. Office of Nutrition Research (ONR) ONR is interested in advancing innovative research on NAMs to address the complexities of nutrition, its biology, and its critical role in health across the lifespan for all.

Specific to this topic, ONR is interested in applications that: Improve the precision (measurement, interpretation, and attribution) of assessment of nutritional status as a biological variable. Explore the reciprocal relationships among nutritional status and the processes necessary to achieve that status (i.e., digestion, absorption, metabolism, integration into relevant biological systems, homeostatic control).

Enhance our understanding of the function of single and multiple nutrients and other bioactive components of food within biological systems of interest (e.g., immunocompetence, neurobiology, and metabolism). Explore the relationships among nutrients and other bioactive components of food with xenobiotics. IC may give special consideration to support meritorious applications in this topic area.

This office does not award grants. Applications must be relevant to the objectives of at least one of the participating Institutes or Centers listed in this topic. National Heart, Lung, and Blood Institute (NHLBI) The NHLBI is interested in research to stimulate understanding of the impact of dietary and supplement intake on metabolic processes and outcomes related to heart, lung, blood, sleep (HLBS) diseases and conditions.

Specific research interests include studies that: Examine interactions between food- and dietary supplement-induced changes (e.g., gene expression, omics, inflammation) to improve outcomes Investigate the biological, behavioral, and/or psychosocial mechanisms of dietary interventions (e.g., DASH, Mediterranean diets) or supplements and their impact Validate dietary assessment methodologies and noninvasive biomarkers (e.g., circulating metabolites) as indicators of dietary exposure and biological responses Leverage artificial intelligence/machine learning and big data to improve understanding of physiological mechanisms of diet and its influence on HLBS diseases and outcomes Assess nutrient–drug and supplement–drug interactions relevant to HLBS diseases and outcomes IC may dedicate funds available to support applications in this Topic area depending upon the availability of funds, the number of meritorious applications, and competing ICO priorities.

IC may give special consideration to support meritorious applications in this topic area. For technical issues E-mail OER Webmaster