RecruitingNot ApplicableNCT05701657

Nutrition for Precision Health, Powered by the All of Us

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


Sponsor

RTI International

Enrollment

8,000 participants

Start Date

Apr 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a large-scale nutrition study, called Nutrition for Precision Health (NPH), that investigates how individuals respond differently to the same foods — a field known as precision nutrition. The study uses a combination of genetic data, blood tests, gut microbiome profiling, and controlled diet experiments to understand the personal factors that determine how different foods affect a person's health and metabolism. You may be eligible if: - You are 18 years of age or older - You have completed the primary All of Us Research Program enrollment and consent procedures (including EHR consent and providing a biospecimen for DNA sequencing) - You speak English or Spanish - You are able and willing to comply with study requirements - For Modules 2 and 3: you must have completed Module 1 and agree to follow controlled diet protocols for approximately 10–12 weeks You may NOT be eligible if: - You have had bariatric surgery in the past 12 months - You are currently receiving or in hospice or palliative care for a terminal illness - You have severe food allergies to components of the study meals - You are currently incarcerated or no longer living in the United States - You have uncontrolled hypertension, diabetes with HbA1c above 12%, or other serious uncontrolled chronic conditions - You are pregnant and cannot complete the module before 36 weeks of gestation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiet A

This diet has high amounts of fruits/vegetables, whole grains, and beans, moderate amounts of dairy, meat/poultry/eggs, nuts/seeds, and olive oil, and very low amounts of sugar sweetened drinks and desserts.

OTHERDiet B

This diet has high amounts of refined grains, meat/poultry/egg, sugar sweetened drinks, snacks, desserts, and processed foods. It has a moderate amount of dairy and low amounts of fruits/vegetables, whole grains, and fish.

OTHERDiet C

This diet has moderate-high amounts of vegetables, meat/poultry/egg, nuts/seeds, dairy and fats/oils, low amounts of fruits, and very low amounts of grains and sugars.


Locations(14)

University of Alabama at Birmingham

Birmingham, Alabama, United States

USDA Western Human Nutrition Research Center

Davis, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

Cedars Sinai Medical Center

West Hollywood, California, United States

Northwestern University

Chicago, Illinois, United States

Illinois Institute of Technology

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

Tufts University

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of North Carolina at Chapel Hill - Chapel Hill Clinic

Chapel Hill, North Carolina, United States

University of North Carolina at Chapel Hill - Kannapolis

Kannapolis, North Carolina, United States

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NCT05701657


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