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New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition research
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Topic Description
Post Date: May 20, 2026
Expiration Date: May 20, 2028
Background
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.
Purpose
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
It aligns with:
- 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.
Participating ICOs
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.
Adam J. Kuszak, Ph.D.
[email protected]
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)
[email protected]
Lisa Neuhold, PhD (Cell and Molecular Technologies, Photoreceptor/RPE Biology)
[email protected]
Hongman Song, PhD (Glaucoma)
[email protected]
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
Monica Serra, Ph.D.
[email protected]
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).
Christopher Lynch, Ph.D
[email protected]
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.
Daniel Raiten, Ph.D.
[email protected]
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