Personalized Responses to Dietary Composition Trial 3
1 other identifier
interventional
250,000
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jul 2020
Longer than P75 for not_applicable diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
April 16, 2025
April 1, 2025
9.5 years
January 13, 2021
April 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Glucose
Measurement of blood glucose by continuous glucose monitor (mmol/L)
6-14 days
Gut microbiome species richness
Species count in fecal sample (as part of ZOE testing program)
1 day
Blood Lipids
Measurement of baseline and 6-h post-prandial triglycerides (mmol/L) by dried blood sample (as part of ZOE testing program)
1 day
Hunger and appetite assessment
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
6-14 days
Glucose and HbA1c
Measurement of baseline glucose (mmol/L) and HbA1c (%) by dried blood sample (as part of ZOE testing program)
2 days
Secondary Outcomes (7)
Dietary assessment
6-14 days
Anthropometry
1 day
Anthropometry
1 day
Dietary assessment
1 month
Bowel Type and Habit
6-14 days
- +2 more secondary outcomes
Other Outcomes (8)
Adherence (in sub-cohort)
Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)
Hunger (in sub-cohort)
Time Frame: 12 months: Baseline, Daily (0 to 4 weeks), monthly (5 to 52 weeks)
Weight (in sub-cohort)
Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)
- +5 more other outcomes
Study Arms (1)
Dietary Intervention
EXPERIMENTALDietary intervention using standardized test meals after which the postprandial metabolic response is measured.
Interventions
To carry out a dietary intervention using standardized test meals, where the participant's postprandial response to the meal is measured and is used to predict their postprandial responses to other foods, along with input variables including metabolic profile, anthropometry, sleep and exercise.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Zoe Global Limitedlead
- Massachusetts General Hospitalcollaborator
- Stanford Universitycollaborator
- Harvard School of Public Health (HSPH)collaborator
Study Sites (2)
Zoe US Inc.
Needham, Massachusetts, 02494, United States
King's College London
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Spector, PhD
Zoe Global Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2021
First Posted
February 3, 2021
Study Start
July 20, 2020
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
April 16, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share