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Nutrition for Precision Health, Powered by the All of Us
NCT05701657 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Diet A
- OTHER Diet B
- OTHER Diet C
Study Locations (14)
California
- USDA Western Human Nutrition Research Center — Davis
- University of California, Los Angeles — Los Angeles
- University of California, Davis — Sacramento
- Cedars Sinai Medical Center — West Hollywood
Illinois
- Northwestern University — Chicago
- Illinois Institute of Technology — Chicago
- University of Chicago — Chicago
Louisiana
- Pennington Biomedical Research Center — Baton Rouge
- Louisiana State University Health Sciences Center — New Orleans
Massachusetts
- Tufts University — Boston
- Massachusetts General Hospital — Boston
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill Clinic — Chapel Hill
- University of North Carolina at Chapel Hill - Kannapolis — Kannapolis
Alabama
- University of Alabama at Birmingham — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,000 participants |
| Start Date | 2023-04-14 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05701657
The ClinicalTrials.gov registry entry for NCT05701657 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RTI International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Nutrition appearing as the primary indexed condition, and to 3 interventions — of which Diet A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05701657 reports 14 study locations spanning 6 distinct geographic areas — top geographies include California, Illinois, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05701657 about?
NCT05701657 is a clinical study titled "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,...
What is the current status of trial NCT05701657?
This trial is currently recruiting. It is a NA study. The enrollment target is 8,000 participants. The study started on 2023-04-14. Estimated completion is 2027-01-31.
What conditions does trial NCT05701657 study?
This clinical trial studies the following conditions: Nutrition, Dietary Habits, Health. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05701657?
The interventions under investigation include: Diet A (OTHER), Diet B (OTHER), Diet C (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05701657?
This trial is sponsored by RTI International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05701657 being conducted?
This trial has 14 study locations across Alabama, California, Illinois, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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