Nutrition for Precision Health, Powered by the All of Us

NCT05701657 | Recruiting DMC

• 16 other identifiers: Pro00062970UG1HD107692U24HD107676UG1HD107691UG1HD107697UG1HD107688UG1HD107696UG1HD107711U54TR004279U24CA268153U24DK131617U24CA268228U24OD023121OT2OD035404OT2OD030043AOD22022001
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Nutrition; Health; Dietary Habits

Outcome Measures

Primary Outcomes (12)

• Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet A

  Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet A.

  4 hours

• Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet A

  Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet A.

  4 hours

• Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet A

  Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet A.

  4 hours

• GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet A

  Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet A.

  4 hours

• Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet B

  Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet B.

  4 hours

• Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet B

  Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet B.

  4 hours

• Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet B

  Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet B.

  4 hours

• GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet B

  Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet B.

  4 hours

• Glucose - Diet Specific mixed meal tolerance test (MMTT) Diet C

  Area under the curve (AUC) for glucose measured during the diet-specific MMTT for Diet C.

  4 hours

• Insulin - Diet Specific mixed meal tolerance test (MMTT) Diet C

  Area under the curve (AUC) for insulin measured during the diet-specific MMTT for Diet C.

  4 hours

• Triglycerides - Diet Specific mixed meal tolerance test (MMTT) Diet C

  Area under the curve (AUC) for triglycerides measured during the diet-specific MMTT for Diet C.

  4 hours

• GLP-1 - Diet Specific mixed meal tolerance test (MMTT) Diet C

  Area under the curve (AUC) for Glucagon-Like Peptide-1 (GLP-1) measured during the diet-specific MMTT for Diet C.

  4 hours

Secondary Outcomes (21)

• Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to known intake from objective measures.

  14 days

• Accuracy of energy intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.

  14 days

• Accuracy of carbohydrate intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.

  14 days

• Accuracy of protein intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.

  14 days

• Accuracy of fat intake estimates from tool (ASA24, mFR, AIM-2, ASA24 record, mFR+ASA24) compared to measured intake from provided diets.

  14 days

Study Arms (2)

Community-Dwelling Controlled-Feeding Arm (Module 2)

EXPERIMENTAL

Participants drawn from Module 1 will receive three standardized diets (A, B, and C) in one of six sequences. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. All meals are provided while participants remain living in their own homes. Each diet period lasts \~14 days, separated by washouts of at least 14 days. Participants are masked to the nutritional content of each diet. Data collection includes wearable device outputs, physical and contextual assessments, and biospecimens. This arm evaluates metabolic responses to controlled diets under real-world, community-dwelling conditions.

Other: Diet A; Other: Diet B; Other: Diet C

Residential Controlled-Feeding Arm (Module 3)

EXPERIMENTAL

A separate group of participants drawn from Module 1, who are not enrolled in Module 2, will receive the same three standardized diets administered in Module 2 while residing in a fully supervised residential setting. Diet sequences are assigned at the cohort level based on a pre-defined site-specific schedule. Each diet period will last approximately 14 days and will be separated by washout periods of at least 14 days. Intake, activity, and sleep will be closely monitored. Participants will also complete the same liquid meal test administered in Module 1 (see detailed description) after each of the diet periods. A wealth of measurements will be collected, including data from wearables, physical and contextual measures, and biospecimens. Intake balance studies are conducted in this module using the doubly labeled water assessments and DXA for body composition. Module 3 is designed to isolate the response to different diets from behavioral variability observed in community settings.

Other: Diet A; Other: Diet B; Other: Diet C

Interventions

Diet A OTHER

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.

Community-Dwelling Controlled-Feeding Arm (Module 2); Residential Controlled-Feeding Arm (Module 3)

Diet B OTHER

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.

Community-Dwelling Controlled-Feeding Arm (Module 2); Residential Controlled-Feeding Arm (Module 3)

Diet C OTHER

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.

Community-Dwelling Controlled-Feeding Arm (Module 2); Residential Controlled-Feeding Arm (Module 3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• RTI International: lead
• 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

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

USDA Western Human Nutrition Research Center

Davis, California, 95616, United States

RECRUITING

University of California, Los Angeles

Los Angeles, California, 90024, United States

RECRUITING

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

Cedars Sinai Medical Center

West Hollywood, California, 90069, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Tufts University

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of North Carolina at Chapel Hill - Chapel Hill Clinic

Chapel Hill, North Carolina, 27514, United States

RECRUITING

University of North Carolina at Chapel Hill - Kannapolis

Kannapolis, North Carolina, 28081, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Marie G Gantz, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn P Huitema, MS

CONTACT

833-947-2583; info@nutritionforprecisionhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to the 3 different diets (i.e., Diet A, Diet B, Diet C).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants receive three standardized diets in a community-dwelling (Module 2) or live-in/residential settings (Module 3) setting.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 27, 2023
• Study Start: April 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after study completion
• Access Criteria: Per the policies of the All of Us Research Workbench

Locations

US (14)