Nutrition for Precision Health, Powered by the All of Us

The goal of this Nutrition for Precision Health (NPH) powered by All of Us research study is to develop Artificial Intelligence/Machine Learning (AI/ML) algorithms that predict individual responses to diet patterns using rich multimodal data streams collected across multiple domains (e.g., behavior, social, environmental, clinical and molecular biomarkers). NPH includes a large phenotyping cohort (Module 1, N=8000) and two separate follow-up groups drawn from a subset of Module 1participants. One group (Module 2, N=1200) receives three distinct diets in a 14-day crossover sequence, with at least a 14-day washout period between diets, while living in their own homes. A second group (Module 3, N=150) receives the same three diets under full-time supervision in a residential research setting. We will train and test AI/ML models to predict 0-4 hour postprandial response curves for glucose, insulin, triglycerides, and GLP-1, to the standardized diet-specific meal test (DSMT) collected after each of the three different diets delivered in Module 2. Each diet functions as a controlled stimulus to reveal biological features (such as individual variables, patterns, or clusters of measurements) that best predict a person's response. The Module 2 DSMT response curves are the primary outcomes (dependent variables) for AI/ML algorithms that predict individual responses to diet patterns. As a secondary objective, NPH will evaluate the validity and acceptability of technology-based dietary assessment tools. The Automated Self-Administered 24-hour recall (ASA24), Automatic Ingestion Monitor-2 (AIM-2), and the mobile food record (mFR) will be evaluated in Modules 2 and 3, and the ASA24 food record and the image-assisted ASA24 recall will be evaluated only in Module 3. Total energy intake, macronutrient and dietary fiber intake data are the main outcomes for validity testing compared against measures of actual intake. Acceptability will be determined from feedback surveys.

NCT Number	NCT05701657
Lead Sponsor	RTI International Collaborators: National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Northwestern University, Illinois Institute of Technology, University of Chicago, Pennington Biomedical Research Center, Louisiana State University Health Sciences Center in New Orleans, University of California, Davis, University of California, Los Angeles, Cedars-Sinai Medical Center, University of Alabama at Birmingham, Tufts University, Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), City University of New York, School of Public Health, Mayo Clinic, University of California, San Diego, University of Hawaii, Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Drug Abuse, Public Health Informatics Computational and Operations Research, University of Southern California, Cornell University, University of Alabama, Tuscaloosa, North Carolina State University, University of North Carolina, Charlotte, Duke University, Stevens Institute of Technology, Purdue University, United States Military Academy West Point, USDA, Western Human Nutrition Research Center, North Carolina Central University, Wake Forest University Health Sciences, Boston University, Children's Hospital of Richmond, Virginia Commonwealth University, Verily Life Sciences LLC, Indiana University, Fred Hutchinson Cancer Center, Columbia University, University of Pennsylvania
Conditions	Nutrition, Health, Dietary Habits
Enrollment	8,000 participants
Start Date	2023-04-14
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-15