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NCT05701657 · ClinicalTrials.gov registry record · NA

Nutrition for Precision Health, Powered by the All of Us

A NA study of Nutrition and Dietary Habits, sponsored by RTI International.

Recruiting
Registry status
NA
Development phase
8,000
Enrollment target
14
Study locations

NCT05701657 is a NA study of Nutrition and Dietary Habits that is actively recruiting participants, run by RTI International. The registered enrollment target is 8,000 participants, above the 2,845-participant average among 22 other Nutrition trials with a reported enrollment target (181% higher). The trial reports 14 study locations across 6 states.

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The verdict

NCT05701657, a NA study of Nutrition and Dietary Habits, is actively recruiting participants, sponsored by RTI International.

RECRUITING
Registry status
NA
Development phase
8,000 participants
Enrollment target
14
Study locations

Study 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.

Interventions

  • OTHER Diet A
  • OTHER Diet B
  • OTHER Diet C

Study Locations (14)

California

  • USDA Western Human Nutrition Research Center - Davis
  • University of California, Los Angeles - Los Angeles
  • University of California, Davis - Sacramento
  • Cedars Sinai Medical Center - West Hollywood

Illinois

  • Northwestern University - Chicago
  • Illinois Institute of Technology - Chicago
  • University of Chicago - Chicago

Louisiana

  • Pennington Biomedical Research Center - Baton Rouge
  • Louisiana State University Health Sciences Center - New Orleans

Massachusetts

  • Tufts University - Boston
  • Massachusetts General Hospital - Boston

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill Clinic - Chapel Hill
  • University of North Carolina at Chapel Hill - Kannapolis - Kannapolis

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 8,000 participants
Start Date 2023-04-14
Est. Completion 2027-01-31
Phase NA

Sponsor

RTI International

45 total trials

What the Registry Record Tells You About NCT05701657

The ClinicalTrials.gov registry entry for NCT05701657 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 8,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,845-participant average among 22 other Nutrition trials with a reported enrollment target (181% higher). The listed sponsor is RTI International, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Nutrition appearing as the primary indexed condition, and to 3 interventions - of which Diet A is the first listed.

NCT05701657 reports 14 study locations spanning 6 distinct geographic areas - top geographies include California, Illinois, Louisiana.

Frequently Asked Questions

What is clinical trial NCT05701657 about?

NCT05701657 is a clinical study titled "Nutrition for Precision Health, Powered by the All of Us". 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,...

What is the current status of trial NCT05701657?

This trial is currently recruiting. It is a NA study. The enrollment target is 8,000 participants. The study started on 2023-04-14. Estimated completion is 2027-01-31.

What conditions does trial NCT05701657 study?

This clinical trial studies the following conditions: Nutrition, Dietary Habits, Health.

What interventions are being tested in trial NCT05701657?

The interventions under investigation include: Diet A (OTHER), Diet B (OTHER), Diet C (OTHER).

Who is sponsoring clinical trial NCT05701657?

This trial is sponsored by RTI International, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05701657 being conducted?

This trial has 14 study locations across Alabama, California, Illinois, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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