About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Single group
Treatments tested in this trial
Dietary Intervention
Other 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.
Treatment groups
Trial outcomes
Primary outcomes
Glucose
Measurement of blood glucose by continuous glucose monitor (mmol/L)
Gut microbiome species richness
Species count in fecal sample (as part of ZOE testing program)
Blood Lipids
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
Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)
Secondary outcomes
Dietary assessment
Weighed food log
Anthropometry
Weight (kg) (as part of ZOE testing program)
Anthropometry
Height (cm) (as part of ZOE testing program)
Dietary assessment
Diet history and portion size questionnaire about the preceding month (as part of ZOE testing program)
Other outcomes
Adherence (in sub-cohort)
Self-reported in-app question on daily frequency of adherence (categorical)
Hunger (in sub-cohort)
Self-reported in-app question on hunger levels (categorical)
Weight (in sub-cohort)
Body Weight (kg)
Bristol Stool Category (in sub-cohort)
Self-reported in-app Bristol Stool chart question (categorical)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zoe Global Limited
Lead sponsor
Massachusetts General Hospital
Collaborator
Stanford University
Collaborator
Harvard School of Public Health (HSPH)
Collaborator