Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05701657 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Nutrition for Precision Health, Powered by the All of Us

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 56 days later Dec 31, 2026 → Feb 25, 2027
See other at-risk trials from RTI International

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 14 sites
  2. Eligibility criteria expanded, about 80 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 15 of 21 entries
    • Site details revised at 2 of 14 sites
    • Collaborators: details revised at 1 of 46 entries
    • Publications: details revised at 1 of 1 entry
  3. Primary completion pushed from Dec 31, 2026 to Feb 25, 2027
    • Study completion date: Jan 31, 2027 to Feb 25, 2027
    • Site contacts updated at 1 of 14 sites
    v25
  4. Site contacts updated at 1 of 14 sitesv24
  5. Site details revised at 1 of 14 sitesv23
Show 2 earlier versionsHide 2 earlier versions
  1. Site contacts updated at 1 of 14 sitesv22
  2. Site contacts updated at 2 of 14 sitesv21
  1. Primary completion moved earlier from Feb 28, 2027 to Dec 31, 2026
    • Study completion date: Feb 28, 2027 to Jan 31, 2027
    v20
  2. Primary completion date: Dec 31, 2026 to Feb 28, 2027
    • Study completion date: Jan 31, 2027 to Feb 28, 2027
    v19
  3. Primary endpoints: 3 to 12v18 Show 5 more changesShow less
    • Interventions: Diet A (Other), Diet B (Other), Diet C (Other), Diet-Specific Mixed Meal Tolerance Test (Other), Liquid Mixed Meal Tolerance Test (Other) to Diet A (Other), Diet B (Other), Diet C (Other)
    • Secondary endpoints expanded, about 229 words
    • Study description expanded, about 783 words
    • Study arms: 3 to 2
    • Eligibility criteria shortened, about 1 word
  4. Site details revised at 14 of 14 sitesv17
  5. Eligibility criteria expanded, about 14 wordsv16
  6. Enrollment target: 10000 to 8000
    • Site contacts updated at 14 of 14 sites
    v15
  7. Re-verified, no change to tracked fieldsv14
  8. Study sites revised (14)v13
  9. Eligibility criteria expanded, about 29 words
    • Site details revised at 1 of 14 sites
    v12
  10. Site details revised at 2 of 14 sitesv11
  11. Site details revised at 1 of 14 sitesv10
  12. Study sites: 13 to 14v9
  13. Site details revised at 2 of 13 sitesv8
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 30, 2023 to Apr 14, 2023
    • Site details revised at 13 of 13 sites
    v7
  15. Interventions: Diet A (Other), Diet B (Other), Diet C (Other), Diet-Specific Meal Test (Other), Liquid Mixed Meal Tolerance Test (Other) to Diet A (Other), Diet B (Other), Diet C (Other), Diet-Specific Mixed Meal Tolerance Test (Other), Liquid Mixed Meal Tolerance Test (Other)
    • Study description revised
    • Site contacts updated at 5 of 13 sites
    • Eligibility criteria shortened, about 4 words
    v6
  16. Start date: Mar 20, 2023 to Mar 30, 2023
    • Site contacts updated at 1 of 13 sites
    v5
  17. Site contacts updated at 1 of 13 sitesv4
  18. Start date: Feb 15, 2023 to Mar 20, 2023
    • Study sites revised (13)
    v3
  19. Collaborators: 22 to 46v2
  20. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05701657
Lead Sponsor RTI International
Collaborators: National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Northwestern University, Illinois Institute of Technology, University of Chicago, Pennington Biomedical Research Center, Louisiana State University Health Sciences Center in New Orleans, University of California, Davis, University of California, Los Angeles, Cedars-Sinai Medical Center, University of Alabama at Birmingham, Tufts University, Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), City University of New York, School of Public Health, Mayo Clinic, University of California, San Diego, University of Hawaii, Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Drug Abuse, Public Health Informatics Computational and Operations Research, University of Southern California, Cornell University, University of Alabama, Tuscaloosa, North Carolina State University, University of North Carolina, Charlotte, Duke University, Stevens Institute of Technology, Purdue University, United States Military Academy West Point, USDA, Western Human Nutrition Research Center, North Carolina Central University, Wake Forest University Health Sciences, Boston University, Children's Hospital of Richmond, Virginia Commonwealth University, Verily Life Sciences LLC, Indiana University, Fred Hutchinson Cancer Center, Columbia University, University of Pennsylvania
Conditions
(from sponsor)		 Nutrition, Health, Dietary Habits
Related terms Feeding Behavior
Enrollment 8,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov