Nutrition for Precision Health, Powered by the All of Us
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRTI International
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Diet A
- Diet B
- Diet C
Treatment groups
8,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
RTI International
Lead sponsor
National Institutes of Health (NIH)
Collaborator
University of North Carolina, Chapel Hill
Collaborator
Northwestern University
Collaborator
Illinois Institute of Technology
Collaborator
University of Chicago
Collaborator
Pennington Biomedical Research Center
Collaborator
Louisiana State University Health Sciences Center in New Orleans
Collaborator
University of California, Davis
Collaborator
University of California, Los Angeles
Collaborator
Cedars-Sinai Medical Center
Collaborator
University of Alabama at Birmingham
Collaborator
Tufts University
Collaborator
Massachusetts General Hospital
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
National Cancer Institute (NCI)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
City University of New York, School of Public Health
Collaborator
Mayo Clinic
Collaborator
University of California, San Diego
Collaborator
University of Hawaii
Collaborator
Vanderbilt University Medical Center
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
National Institute of Drug Abuse
Collaborator
Public Health Informatics Computational and Operations Research
Collaborator
University of Southern California
Collaborator
Cornell University
Collaborator
University of Alabama, Tuscaloosa
Collaborator
North Carolina State University
Collaborator
University of North Carolina, Charlotte
Collaborator
Duke University
Collaborator
Stevens Institute of Technology
Collaborator
Purdue University
Collaborator
United States Military Academy West Point
Collaborator
USDA, Western Human Nutrition Research Center
Collaborator
North Carolina Central University
Collaborator
Wake Forest University Health Sciences
Collaborator
Boston University
Collaborator
Children's Hospital of Richmond
Collaborator
Virginia Commonwealth University
Collaborator
Verily Life Sciences LLC
Collaborator
Indiana University
Collaborator
Fred Hutchinson Cancer Center
Collaborator
Columbia University
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov