Personalized dietary responses for better health
Personalized Responses to Dietary Composition Trial 3
This study is testing how different foods affect people's health based on their unique responses, and it's for individuals taking part in the ZOE testing program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zoe Global Limited Academic / other |
| Locations | 2 sites (Needham, Massachusetts and 1 other locations) |
| Trial ID | NCT04735835 on ClinicalTrials.gov |
What this trial studies
The PREDICT 3 study aims to enhance precision nutrition by analyzing individual responses to food through machine learning models. Participants, who must be enrolled in the ZOE testing program, will undergo a dietary intervention involving standardized meals and a free-living period to track their dietary habits. The study will assess how various factors like exercise and sleep influence metabolic responses after meals. This research builds on previous findings from over 2,000 individuals and utilizes a commercial product to gather extensive data from participants.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are enrolled in the ZOE testing program and have a BMI of at least 16.5 kg/m2.
Not a fit: Patients who cannot safely consume the standardized meals due to allergies or other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized dietary recommendations that improve metabolic health for individuals with diabetes and heart diseases.
How similar studies have performed: Previous studies in this area have shown promise in personalizing nutrition based on individual metabolic responses, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Needham, Massachusetts and 1 other locations
- Zoe US Inc. — Needham, Massachusetts, United States (Recruiting)
- King's College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tim Spector, PhD — Zoe Global Limited
- Study coordinator: Meaghan Reardon
- Email: meaghan@joinzoe.com
- Phone: 866-771-7478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.