Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center

PROJECT SUMMARY/ABSTRACT The overarching goal of the proposed RTI International–Cornell Research Coordinating Center (RCC) is to provide seamless operational support and multidisciplinary experience for building consensus in the Nutrition for Precision Health Consortium (NPHC). In the 1-year planning phase, we will prioritize efficiency and objectivity in facilitating the design of diet modules (1: usual dietary assessment; 2: controlled feeding dietary intervention; and 3: domiciled dietary intervention) nested in All of Us and their research protocols. In the 4- year implementation phase, we will facilitate the implementation of Modules 1–3, enable the flow of quality data and specimens across the NPHC, and integrate curated, Artificial intelligence (AI)–ready data into the All of Us Researcher Workbench, using our established data coordination processes and systems. Innovations in our approach include tools for conducting dietary studies in hard-to-reach populations, idiographic (or subject-as-own-control) clinical trials, and wearables research tools and analytics. Specifically, the proposed RCC will excel in administrating and coordinating NPHC and its research initiatives, clinical interventions, and data and biospecimen sharing, as follows: Aim 1: Optimize the scientific rigor of Modules 1–3 Aim 2: Ensure NPHC study data are FAIR (Findable, Accessible, Interoperable, and Reusable) Aim 3: Enable seamless data collection, curation, and transfer including to the Researcher Workbench Aim 4: Minimize time to launch of Modules 1–3 Aim 5: Maximize the efficiency of consortium communications and collaborations NPHC is being launched to address major research gaps in nutrition; the nature of these gaps and the complexity of the NPHC activities cannot be underscored enough. RCC will be led by Multiple Principal Investigators with complementary expertise in coordinating center and multisite leadership and biostatistics (Dr. Gantz at RTI) and nutritional intervention and clinical expertise (Dr. Mehta at Cornell University) with the support of a strong and diverse team, organized around cores for Design and Analytics, Data Curation and Systems, and Study Implementation. Other key components include single IRB and medical safety monitoring. The RCC will also benefit from our collective institutional strengths, with an expert pool of wide- ranging research and clinical backgrounds pertinent to the NPHC (e.g., omics, bioinformatics, AI, clinical trial intervention, nutritional assessment). The proposed RCC is immediately and amply prepared to support to NPHC in its mission to develop clinically meaningful algorithms that predict individual responses to food and dietary patterns and to improve health across diverse U.S. populations.