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Recruiting Not applicable Interventional Accepts healthy volunteers

Nutrition for Precision Health, Powered by the All of Us

ClinicalTrials.gov ID: NCT05701657

Public ClinicalTrials.gov record NCT05701657. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 7:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Nutrition for Precision Health, Powered by the All of Us Research Program

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05701657
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
RTI International
Other
Enrollment
8,000 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 13, 2023
Primary completion
Dec 30, 2026
Completion
Jan 30, 2027
Last update posted
Jul 14, 2026

2023 – 2027

United States locations

U.S. sites
14
U.S. states
6
U.S. cities
10
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 Recruiting
University of California, Davis Davis California 95616 Recruiting
USDA Western Human Nutrition Research Center Davis California 95616 Recruiting
University of California, Los Angeles Los Angeles California 90024 Recruiting
Cedars Sinai Medical Center West Hollywood California 90069 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
Illinois Institute of Technology Chicago Illinois 60616 Recruiting
University of Chicago Chicago Illinois 60637 Recruiting
Pennington Biomedical Research Center Baton Rouge Louisiana 70808 Recruiting
Louisiana State University Health Sciences Center New Orleans Louisiana 70112 Recruiting
Tufts University Boston Massachusetts 02111 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
University of North Carolina at Chapel Hill - Chapel Hill Clinic Chapel Hill North Carolina 27514 Recruiting
University of North Carolina at Chapel Hill - Kannapolis Kannapolis North Carolina 28081 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05701657, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05701657 live on ClinicalTrials.gov.

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