DiabetesNCT04735835
Personalized Responses to Dietary Composition Trial 3
A study testing Dietary Intervention in people with Diabetes and Heart Diseases, run by Zoe Global Limited at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Heart Diseases, Diet Habit
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jul 2020to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Zoe US Inc.
Needham, Massachusetts, 02494
Brad Reardon, +1866-771-7478, hello@joinzoe.com
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London
Inbar Linenberg, inbar@joinzoe.com
Sarah Berry, sarah.e.berry@kcl.ac.uk
About this study
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.
Read the 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 in the PREDICT 3 research program.
Screening Assessment: The study eligibility criteria listed below closely match to the commercial eligibility criteria, which ZOE users consent to before enrolling in the commercial program.
Study duration: Each participant will take part in the study for 6-14 days.
Dietary intervention: The dietary intervention will be carried out on up to 6 days with the option to continue monitoring for a total study period of 14-days. On day one, participants will be asked to fit glucose monitor. Over the following consecutive days, each participant will be instructed to eat 2 standardized meals. Participants are free to eat whatever they wish at all other times. The standardized meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be asked to consume the entire amount of food indicated for the standardized meals and to record any left-over food via a digital app for which training will be provided at the start of the study. Following completion of standardized meal period, participants are free to eat and drink whatever they wish and will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study.
Regular contact will be made with the participants via phone, their app and text messages for the period of the intervention to encourage compliance and answer any queries.
Anthropometry: The participant will be instructed to report height and weight.
Dietary and Lifestyle: Participants will be asked to complete a baseline questionnaire online, as well as a diet history questionnaire with portion sizes about the month preceding their study period. They will be asked to record on a daily basis their dietary, activity, and psychological data (e.g. hunger) using a digital mobile phone app. Training in all apps and equipment will be given through written and online instructions and via communications with the study support staff.
Digital devices: Participants will be asked to record daily dietary and activity information using digital apps and lifestyle information will be monitored using a wearable device. The continuous glucose monitor (Freestyle Libre, CGM) provides continuous glucose profiles for up to 14 days. The CGM will be inserted on the back of the upper arm, one day before participants begin dietary intervention. This will measure subcutaneous interstitial fluid glucose concentrations every 5 minutes. The CGM will be removed at the end of the intervention period by the participant. A contact number will be made available to participants for any inquiries or if any problems arise. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected.
Meal responses: As a product user, the participant will consume standardized meals an additional day to the study intervention.
Blood samples: As a product user, the participant will collect postprandial blood on 1 day using finger-prick blood sampling.
Stool sample: As a product user, the participant will collect a stool sample on 1 day.
Digital app: As product users, participants will be asked to download an app designed specifically for this study, which provides diet logging functionality similar to widely used existing apps such as MyFitnessPal.
Participants will be asked to record and monitor the following information via the digital app:
- All food and drink they consume, with serving sizes and photos
- Sleep and physical activity patterns, including exercise
- Hunger and alertness ratings
- Psychological feeling of energy and mood
- Prescription and over-the-counter drug consumption
The app will be available in versions for iOS operating systems. The app will synchronize remotely with backend database servers, over an encrypted and authenticated API, and will support offline operation for when patients wish to record an entry without network coverage. This continuous background synchronization means that it will not be necessary to explicitly download data from the phone at the end of the study.
Following the 2020 pandemic of COVID-19, participants are asked to use the COVID-19 Symptom Tracker app to record their physical health symptoms, or lack thereof, attributable to COVID-19, as well as demographic and other health information to track the spread of disease in real time, and to potentially reveal risk factors for infection and severe illness.
Subcohort: An opt-in follow-on study will be offered to participants to follow dietary guidance from the ZOE app based on their PREDICT 3 results. During the first 4 weeks, participants will be given dietary guidance to follow from the ZOE app. Thereafter, for a period of up to 12 months, participants will be asked to report on outcome measures at regular intervals (monthly). Outcome measures will be reported before, during and after the 4 week period and include weight, bristol stool chart, bowel habits, hunger, energy, adherence to dietary advice, and app usage. Participants (UK only) will collect additional stool samples at variable intervals.
The data will be used to test the efficacy of the ZOE dietary advice in promoting weight loss and improvement of overall health, and may be stratified by age, sex, BMI, adherence and/or motivation to take part in the PREDICT 3 study.
Food Frequency Questionnaire Validation: A food-frequency questionnaire (FFQ) developed using the most frequently logged foods within the ZOE app will be validated against a 4-day period of food logging in the app as well as the commonly used US-based DHQ3 FFQ (target enrollment; n=100).
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Healthy, Obesity
- Being tested
- Dietary Intervention
- Keywords
- Gut microbiome, Personalised nutrition, Machine learning, Postprandial metabolism, Metabolic health
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Feeding Behavior, Obesity, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Dietary intervention using standardized test meals after which the postprandial metabolic response is measured. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Measurement of blood glucose by continuous glucose monitor (mmol/L)
Measured: 6-14 days
Gut microbiome species richness
Species count in fecal sample (as part of ZOE testing program)
Measured: 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)
Measured: 1 day
Hunger and appetite assessment
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
Measured: 6-14 days
Glucose and HbA1c
Measurement of baseline glucose (mmol/L) and HbA1c (%) by dried blood sample (as part of ZOE testing program)
Measured: 2 days
Secondary outcomes (7)
Dietary assessment
Weighed food log
Measured: 6-14 days
Anthropometry
Weight (kg) (as part of ZOE testing program)
Measured: 1 day
Anthropometry
Height (cm) (as part of ZOE testing program)
Measured: 1 day
Dietary assessment
Diet history and portion size questionnaire about the preceding month (as part of ZOE testing program)
Measured: 1 month
Bowel Type and Habit
Measurement by Bristol Stool Chart and Questionnaire (as part of ZOE testing program)
Measured: 6-14 days
Perceived Energy Assessment
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
Measured: 6-14 days
Covid-19 symptom assessment
Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis (as part of ZOE testing program)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start20 Jul 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zoe Global Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Tim Spector, PhD, Principal investigator, Zoe Global Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735835
- Sponsor's protocol ID
- PREDICT 3
- Status last verified
- Apr 2025
- First submitted
- 13 Jan 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Responses to Dietary Composition Trial 3
- ClinicalTrials.gov ID
- NCT04735835
- Acronym / sponsor ID
- PREDICT 3
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Healthy, Obesity
- Keywords
- Gut microbiome, Personalised nutrition, Machine learning, Postprandial metabolism, Metabolic health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- Zoe Global LimitedUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, Harvard School of Public Health (HSPH)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 in the PREDICT 3 research program.
Screening Assessment: The study eligibility criteria listed below closely match to the commercial eligibility criteria, which ZOE users consent to before enrolling in the commercial program.
Study duration: Each participant will take part in the study for 6-14 days.
Dietary intervention: The dietary intervention will be carried out on up to 6 days with the option to continue monitoring for a total study period of 14-days. On day one, participants will be asked to fit glucose monitor. Over the following consecutive days, each participant will be instructed to eat 2 standardized meals. Participants are free to eat whatever they wish at all other times. The standardized meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be asked to consume the entire amount of food indicated for the standardized meals and to record any left-over food via a digital app for which training will be provided at the start of the study. Following completion of standardized meal period, participants are free to eat and drink whatever they wish and will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study.
Regular contact will be made with the participants via phone, their app and text messages for the period of the intervention to encourage compliance and answer any queries.
Anthropometry: The participant will be instructed to report height and weight.
Dietary and Lifestyle: Participants will be asked to complete a baseline questionnaire online, as well as a diet history questionnaire with portion sizes about the month preceding their study period. They will be asked to record on a daily basis their dietary, activity, and psychological data (e.g. hunger) using a digital mobile phone app. Training in all apps and equipment will be given through written and online instructions and via communications with the study support staff.
Digital devices: Participants will be asked to record daily dietary and activity information using digital apps and lifestyle information will be monitored using a wearable device. The continuous glucose monitor (Freestyle Libre, CGM) provides continuous glucose profiles for up to 14 days. The CGM will be inserted on the back of the upper arm, one day before participants begin dietary intervention. This will measure subcutaneous interstitial fluid glucose concentrations every 5 minutes. The CGM will be removed at the end of the intervention period by the participant. A contact number will be made available to participants for any inquiries or if any problems arise. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected.
Meal responses: As a product user, the participant will consume standardized meals an additional day to the study intervention.
Blood samples: As a product user, the participant will collect postprandial blood on 1 day using finger-prick blood sampling.
Stool sample: As a product user, the participant will collect a stool sample on 1 day.
Digital app: As product users, participants will be asked to download an app designed specifically for this study, which provides diet logging functionality similar to widely used existing apps such as MyFitnessPal.
Participants will be asked to record and monitor the following information via the digital app:
- All food and drink they consume, with serving sizes and photos
- Sleep and physical activity patterns, including exercise
- Hunger and alertness ratings
- Psychological feeling of energy and mood
- Prescription and over-the-counter drug consumption
The app will be available in versions for iOS operating systems. The app will synchronize remotely with backend database servers, over an encrypted and authenticated API, and will support offline operation for when patients wish to record an entry without network coverage. This continuous background synchronization means that it will not be necessary to explicitly download data from the phone at the end of the study.
Following the 2020 pandemic of COVID-19, participants are asked to use the COVID-19 Symptom Tracker app to record their physical health symptoms, or lack thereof, attributable to COVID-19, as well as demographic and other health information to track the spread of disease in real time, and to potentially reveal risk factors for infection and severe illness.
Subcohort: An opt-in follow-on study will be offered to participants to follow dietary guidance from the ZOE app based on their PREDICT 3 results. During the first 4 weeks, participants will be given dietary guidance to follow from the ZOE app. Thereafter, for a period of up to 12 months, participants will be asked to report on outcome measures at regular intervals (monthly). Outcome measures will be reported before, during and after the 4 week period and include weight, bristol stool chart, bowel habits, hunger, energy, adherence to dietary advice, and app usage. Participants (UK only) will collect additional stool samples at variable intervals.
The data will be used to test the efficacy of the ZOE dietary advice in promoting weight loss and improvement of overall health, and may be stratified by age, sex, BMI, adherence and/or motivation to take part in the PREDICT 3 study.
Food Frequency Questionnaire Validation: A food-frequency questionnaire (FFQ) developed using the most frequently logged foods within the ZOE app will be validated against a 4-day period of food logging in the app as well as the commonly used US-based DHQ3 FFQ (target enrollment; n=100).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: Dietary InterventionDietary intervention using standardized test meals after which the postprandial metabolic response is measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionTo 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. | Other | Dietary Intervention |
Primary outcome
Glucose
Time frame: 6-14 days
Measurement of blood glucose by continuous glucose monitor (mmol/L)
Gut microbiome species richness
Time frame: 1 day
Species count in fecal sample (as part of ZOE testing program)
Blood Lipids
Time frame: 1 day
Measurement of baseline and 6-h post-prandial triglycerides (mmol/L) by dried blood sample (as part of ZOE testing program)
Hunger and appetite assessment
Time frame: 6-14 days
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
Glucose and HbA1c
Time frame: 2 days
Measurement of baseline glucose (mmol/L) and HbA1c (%) by dried blood sample (as part of ZOE testing program)
7 secondary outcomes
Dietary assessment
Time frame: 6-14 days
Anthropometry
Time frame: 1 day
Anthropometry
Time frame: 1 day
Dietary assessment
Time frame: 1 month
Bowel Type and Habit
Time frame: 6-14 days
Perceived Energy Assessment
Time frame: 6-14 days
Covid-19 symptom assessment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Spector, PhD principal investigator
Zoe Global Limited
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Diabetes and Heart Diseases, run by Zoe Global Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Reardon (866-771-7478, meaghan@joinzoe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose (time frame: 6-14 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.