NCT04735835 Personalized Responses to Dietary Composition Trial 3
| NCT ID | NCT04735835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zoe Global Limited |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 250,000 participants |
| Start Date | 2020-07-20 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250,000 participants in total. It began in 2020-07-20 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Tim Spector, PhD
PRINCIPAL INVESTIGATOR
Zoe Global Limited
Frequently Asked Questions
Who can join the NCT04735835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04735835 currently recruiting?
Yes, NCT04735835 is actively recruiting participants. Contact the research team at meaghan@joinzoe.com for enrollment information.
Where is the NCT04735835 trial being conducted?
This trial is being conducted at Needham, United States, London, United Kingdom.
Who is sponsoring the NCT04735835 clinical trial?
NCT04735835 is sponsored by Zoe Global Limited. The principal investigator is Tim Spector, PhD at Zoe Global Limited. The trial plans to enroll 250,000 participants.
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