Nutrition for Precision Health, Powered by the All of Us (NCT05701657)
Nutrition for Precision Health, Powered by the All of Us Research Program
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
- Diet A (OTHER)
- Diet B (OTHER)
- Diet C (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- University of California, Davis — Davis, California
- USDA Western Human Nutrition Research Center — Davis, California
- University of California, Los Angeles — Los Angeles, California
- Cedars Sinai Medical Center — West Hollywood, California
- Northwestern University — Chicago, Illinois
- Illinois Institute of Technology — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- Pennington Biomedical Research Center — Baton Rouge, Louisiana
- Louisiana State University Health Sciences Center — New Orleans, Louisiana
- Tufts University — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- University of North Carolina at Chapel Hill - Chapel Hill Clinic — Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill - Kannapolis — Kannapolis, North Carolina
📞 Contact the Study Coordinator
Phone: (833) 947-2583
Email: info@nutritionforprecisionhealth.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.