Nutrition for Precision Health, Powered by the All of Us

Recruiting now · Not applicable

Conditions studied: Nutrition, Health, Dietary Habits

In brief

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.

Key facts

Study ID: NCT05701657
Run by: RTI International
People needed: 8000
Starts: 2023-04-14
Expected to finish: 2027-01-31
Last updated by the study team: 2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Overall Inclusion -- Participants 18 years of age or older who have completed the primary All of Us consent process, Electronic Health Record consent process, have provided at least one All of Us biospecimen suitable for DNA sequencing, and have completed All of Us Participant Provided Information (PPI) Modules 1-3 (Basics, Overall Health, and Lifestyle); Speak English or Spanish; Able and willing to comply with study requirements and consent to participate.
Module 1 -- Must be willing and able to comply with Module 1 protocol; Must provide informed consent for Module 1.
Module 2 -- Must have completed Module 1; Must provide informed consent for Module 2; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to six months. This includes consuming only the foods provided during periods of controlled feeding. Module 2 has three controlled feeding periods each lasting approximately two weeks with at least two weeks between feeding periods, and up to 6 months allowed for completion of the Module.
Module 3 -- Must have completed Module 1; Must provide informed consent for Module 3; Must agree to comply with protocol over a period of approximately 10 to 12 weeks and up to 6 months. This includes being domiciled three times, for two weeks each, and consuming only the foods provided during the domiciled periods. There is at least two weeks between domiciled periods, and up to 6 months allowed for completion of the Module.

You may not qualify if…

Module 1
Any change to the participant's status from the time of All of Us enrollment that would render them ineligible for All of Us (e.g., being incarcerated, no longer living in the United States, or withdrawn from that study).
Inability to provide informed consent and engage in informed consent procedures
Participants who suffer from allergic reactions to, or are unwilling to consume, any components of the liquid mixed meal (e.g., milk products, soy products)
Barriers to safe insertion of peripheral IV canula:
Contraindications to peripheral IV canula insertion such as local skin infection, inflammation, trauma or burns if all the upper extremities were involved and there is no unaffected extremity available for IV placement; or
A need for long-term IV access (e.g., ESRD); or
Lymphedema or deep vein thrombosis (DVT) in the extremity of the IV (in the case where another extremity is not available); or
Coagulopathy requiring blood thinning products; or
Arteriovenous (AV) graft or fistula in the extremity of the IV (in the case where another extremity is not available)
Pregnancy-related conditions:
Gestational age precluding completion of the Module by 36 weeks. A pregnant participant should complete visit 1 by gestational age 34 weeks, 0 days and complete Module 1 by week 36.
Severe morning sickness limiting mixed meal tolerance test (MMTT) consumption
Certain types of disease states:
Dumping syndrome or inability to consume the volume of the MMTT liquid
Severe malabsorption such as history of short gut syndrome or need for parenteral or enteral nutrition
Less than 12-months post-metabolic or bariatric surgery
History of chronic pancreatitis (e.g., Cystic fibrosis) complicated by inability to tolerate the volume of the MMTT liquid
Health conditions requiring chronic blood transfusions or iron infusions
Hemoglobin <9.5 g/dL at screening
Serious illness and in hospice or palliative care for terminal disease
Swallowing issues:
Self-reported difficulty tolerating solids or liquids
Aspiration risks that require change in thickness of liquid or dietary modifications
Short term antibiotic use. For example, active antibiotics use for an ongoing acute infection

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
University of California, Davis — Davis, California, United States (enrolling)
USDA Western Human Nutrition Research Center — Davis, California, United States (enrolling)
University of California, Los Angeles — Los Angeles, California, United States (enrolling)
Cedars Sinai Medical Center — West Hollywood, California, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
Illinois Institute of Technology — Chicago, Illinois, United States (enrolling)
University of Chicago — Chicago, Illinois, United States (enrolling)
Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (enrolling)
Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
Tufts University — Boston, Massachusetts, United States (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of North Carolina at Chapel Hill - Chapel Hill Clinic — Chapel Hill, North Carolina, United States (enrolling)
University of North Carolina at Chapel Hill - Kannapolis — Kannapolis, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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