No phaseRecruiting

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 (Academic or other)
Enrolment
8,000 planned
Conditions
Nutrition; Health; Dietary Habits
Interventions
Diet A; Diet B; Diet C
Ages
adults, older adults
Registry
NCT05701657

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

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

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered