Status:
RECRUITING
Personalized Responses to Dietary Composition Trial 3
Lead Sponsor:
Zoe Global Limited
Collaborating Sponsors:
Massachusetts General Hospital
Stanford University
Conditions:
Diabetes
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Choice of design: The study is a single arm mechanistic intervention study. Study population: The subject must have enrolled in the commercial ZOE testing program in order to apply for participation ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
250000 Patients enrolled
Trial Details
Trial ID
NCT04735835
Start Date
July 20 2020
End Date
January 1 2030
Last Update
April 16 2025
Active Locations (2)
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1
Zoe US Inc.
Needham, Massachusetts, United States, 02494
2
King's College London
London, United Kingdom