Actively Recruiting
Nutrition for Precision Health, Powered by the All of Us Research Program
Led by RTI International · Updated on 2026-06-03
8000
Participants Needed
14
Research Sites
4 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
Researchers are conducting the Nutrition for Precision Health (NPH) study, a large-scale research project powered by the All of Us Research Program. The study aims to create artificial intelligence and machine learning algorithms that can predict how individuals respond to different diet patterns. It includes a large observational group and two interventional modules where participants follow controlled diets to better understand biological responses to food. The study includes three modules: Module 1 is observational, where participants undergo detailed health assessments and a liquid meal test over 8 to 10 days. Module 2 involves community-dwelling participants who consume three different standardized diets for about 14 days each, with washout periods between diets, while living at home. Module 3 includes participants residing in a supervised residential setting while consuming the same diets with close monitoring of intake, activity, and sleep. Both Modules 2 and 3 collect extensive biological and behavioral data to train AI models. Participants provide blood samples during diet-specific meal tests to measure glucose, insulin, triglycerides, and GLP-1 responses over four hours. They also wear devices to monitor activity and glucose levels, complete questionnaires, and provide biospecimens. The study evaluates the accuracy of technology-based dietary assessment tools and collects feedback on their acceptability. Total participation time varies by module but can last up to six months for Modules 2 and 3.
CONDITIONS
Brief Title
Nutrition for Precision Health, Powered by the All of Us
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older who have completed the primary All of Us consent process and provided at least one biospecimen suitable for DNA sequencing
- Participants who speak English or Spanish
- Willing and able to comply with study requirements and consent to participate
- For Module 1: willing and able to comply with Module 1 protocol and provide informed consent
- For Module 2: completed Module 1, provide informed consent, agree to follow controlled feeding periods totaling approximately 10 to 12 weeks up to 6 months
- For Module 3: completed Module 1, provide informed consent, agree to reside in supervised settings for three two-week periods with washout intervals, up to 6 months
You will not qualify if you...
- Changes in status that make participant ineligible for All of Us (e.g., incarceration, no longer living in the US)
- Inability to provide informed consent
- Allergic reactions or unwillingness to consume liquid mixed meal components (Module 1)
- Barriers to safe peripheral IV insertion (e.g., skin infection, lymphedema, coagulopathy)
- Pregnancy complications limiting completion by 36 weeks or severe morning sickness
- Certain disease states including dumping syndrome, severe malabsorption, recent bariatric surgery, chronic pancreatitis, chronic blood transfusions, low hemoglobin (<9.5 g/dL)
- Serious illness or hospice care
- Swallowing issues or aspiration risks
- Recent antibiotic use or blood donation
- Instability on GLP-1 agonist medication
- For Module 2 and 3: inability to complete Module 1 critical elements, enrollment in both Modules 2 and 3, inability to adhere to protocol, high-risk pregnancy, uncontrolled diseases, recent hospitalization
- History of eating disorders or major psychiatric disorders with recent hospitalization
- Active infections or malignancy receiving chemotherapy
- Use of insulin for diabetes or certain diabetes medications in older adults
- Ongoing tobacco, alcohol, drug use incompatible with domiciling (Module 3)
- Conditions requiring in-person treatments during domiciling (Module 3)
- Depression or suicidality above specified thresholds (Module 3)
- Inability to perform daily self-care (Module 3)
- Uncontrolled endocrine disorders or pain requiring frequent treatment (Module 3)
- Chronic medications posing safety or logistical issues (Module 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 10 days
Participants undergo comprehensive characterization including clinical measures, biospecimen collection, wearable sensor monitoring, questionnaires, and a liquid meal test over a baseline period.
Multiple assessments during baseline period
Duration - Approximately 10 to 12 weeks up to 6 months
Participants consume three standardized diets in a randomized sequence while living in their own homes. Each diet period lasts about 12 to 14 days, separated by at least 14-day washout periods. Wearable devices and biospecimens are collected throughout.
Repeated visits for diet periods and assessments across 3 diet cycles
Duration - Up to 6 months with three two-week diet periods and washouts
Participants reside in a supervised residential setting to consume the same three diets as Module 2, each lasting about 14 days with washout periods. Intake, activity, and sleep are closely monitored. Additional tests including liquid meal tests and body composition assessments are conducted.
Multiple supervised visits and assessments during residential stay
Trial Site Locations
Total: 14 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California, Davis
Davis, California, United States, 95616
Actively Recruiting
3
USDA Western Human Nutrition Research Center
Davis, California, United States, 95616
Actively Recruiting
4
University of California, Los Angeles
Los Angeles, California, United States, 90024
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5
Cedars Sinai Medical Center
West Hollywood, California, United States, 90069
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6
Northwestern University
Chicago, Illinois, United States, 60611
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7
Illinois Institute of Technology
Chicago, Illinois, United States, 60616
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8
University of Chicago
Chicago, Illinois, United States, 60637
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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
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12
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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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
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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