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Personalized Responses to Dietary Composition Trial 3
The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.
Conditions:
🦠 Diabetes 🦠 Heart Diseases 🦠 Diet Habit 🦠 Diet Modification 🦠 Healthy 🦠 Obesity 🦠 Metabolism 🦠 Microbial Colonization
🗓️ Study Start (Actual) 20 July 2020
🗓️ Primary Completion (Estimated) 20 December 2024
✅ Study Completion (Estimated) 20 December 2024
👥 Enrollment (Estimated) 250000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Needham, Massachusetts, United States
📍 London, United Kingdom

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Enrolled in the commercial ZOE testing program
    • * Any sex
    • * Minimum 18 years of age (minimum 19 years of age in Alabama and Nebraska due to state laws)
    • * Body mass index (BMI) of greater than or equal to 16.5 kg/m2.
    • * Living in the continental US states, other than in New York (excluded from the ZOE testing product also as they are unable to access the dried blood spot service provided by Quest), or living in the UK
    • * Able and willing to comply with the study protocol and provide informed consent.
    • * Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)

    Exclusion Criteria:

    • * Cannot safely eat the pre-made test meals which contain standard US ingredients, e.g. due to allergy or recent gastrointestinal surgery, or are unwilling to consume these foods.
    • * Are pregnant.
    • * Have had a heart attack (myocardial infarction), stroke/transient ischemic attack (TIA), or major surgery in the last two months.
    • * Are unable to read and write in English, as the ZOE app is only available in English.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 January 2021
  • First Submitted that Met QC Criteria 29 January 2021
  • First Posted 3 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 July 2023
  • Last Update Posted 1 August 2023
  • Last Verified July 2023
I'm interested ...!!