Actively Recruiting
Nutrition for Precision Health, Powered by the All of Us
Led by RTI International · Updated on 2026-05-01
8000
Participants Needed
14
Research Sites
198 weeks
Total Duration
On this page
Sponsors
R
RTI International
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Nutrition for Precision Health, Powered by the All of Us
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older who have completed All of Us consent, biospecimen donation, and participant information modules
- Speak English or Spanish
- Willing and able to comply with study requirements and provide consent
- Module 1 participants must provide informed consent and comply with protocol
- Module 2 participants must have completed Module 1, provide consent, and agree to follow controlled feeding for about 10-12 weeks with three diet periods and washouts up to 6 months
- Module 3 participants must have completed Module 1, provide consent, and agree to live in a research setting for three two-week periods with washouts up to 6 months
You will not qualify if you...
- Changes in status making participant ineligible for All of Us (e.g., incarceration, no longer in US)
- Unable to give informed consent
- Allergic reactions or unwillingness to consume liquid mixed meal components (Module 1)
- Barriers to safe peripheral IV insertion such as infections, burns, need for long-term IV access, lymphedema, coagulopathy, or AV graft/fistula
- Pregnancy conditions limiting completion by 36 weeks or severe morning sickness
- Certain diseases including dumping syndrome, severe malabsorption, recent bariatric surgery, chronic pancreatitis, need for transfusions, low hemoglobin (<9.5 g/dL), serious illness in hospice, swallowing difficulties, recent antibiotic use, recent blood donation, unstable GLP-1 agonist use
- For Module 2, exclusions include inability to complete Module 1 critical elements, enrollment in Module 3, inability to adhere to protocol, plans to relocate or travel, high-risk pregnancy, possible alcohol use disorder, obesity surgery complications, uncontrolled diseases, active infections, cancer treatment, dietary restrictions for medical reasons, insulin-dependent diabetes, recent hospitalization for chronic disease, psychiatric conditions, recent cardiac events
- For Module 3, additional exclusions include enrollment in Module 2, inability to abstain from tobacco, alcohol, or drugs for two weeks while domiciled, need for in-person treatments, infant care needs not accommodated, severe depression or suicidality, inability to perform daily self-care, uncontrolled endocrine disorders, chronic pain requiring frequent treatment, and use of chronic prescription medications posing safety issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
USDA Western Human Nutrition Research Center
Davis, California, United States, 95616
Actively Recruiting
3
University of California, Los Angeles
Los Angeles, California, United States, 90024
Actively Recruiting
4
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
5
Cedars Sinai Medical Center
West Hollywood, California, United States, 90069
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Illinois Institute of Technology
Chicago, Illinois, United States, 60616
Actively Recruiting
8
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
9
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
10
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
11
Tufts University
Boston, Massachusetts, United States, 02111
Actively Recruiting
12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
13
University of North Carolina at Chapel Hill - Chapel Hill Clinic
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
14
University of North Carolina at Chapel Hill - Kannapolis
Kannapolis, North Carolina, United States, 28081
Actively Recruiting
Research Team
C
Carolyn P Huitema, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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