Personalized Responses to Dietary Composition Trial 3

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZoe Global Limited

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dietary Intervention

    Other intervention

    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.

Treatment groups

250,000 Participants
are divided into 1 treatment group
Group A: Dietary InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Glucose

Measurement of blood glucose by continuous glucose monitor (mmol/L)

Time frame
6-14 days
2

Gut microbiome species richness

Species count in fecal sample (as part of ZOE testing program)

Time frame
1 day
3

Blood Lipids

Measurement of baseline and 6-h post-prandial triglycerides (mmol/L) by dried blood sample (as part of ZOE testing program)

Time frame
1 day
4

Hunger and appetite assessment

Self-reported in-app question on energy levels (categorical) (as part of ZOE testing program)

Time frame
6-14 days

Secondary outcomes

1

Dietary assessment

Weighed food log

Time frame
6-14 days
2

Anthropometry

Weight (kg) (as part of ZOE testing program)

Time frame
1 day
3

Anthropometry

Height (cm) (as part of ZOE testing program)

Time frame
1 day
4

Dietary assessment

Diet history and portion size questionnaire about the preceding month (as part of ZOE testing program)

Time frame
1 month

Other outcomes

1

Adherence (in sub-cohort)

Self-reported in-app question on daily frequency of adherence (categorical)

Time frame
Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)
2

Hunger (in sub-cohort)

Self-reported in-app question on hunger levels (categorical)

Time frame
Time Frame: 12 months: Baseline, Daily (0 to 4 weeks), monthly (5 to 52 weeks)
3

Weight (in sub-cohort)

Body Weight (kg)

Time frame
Time Frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 52 weeks)
4

Bristol Stool Category (in sub-cohort)

Self-reported in-app Bristol Stool chart question (categorical)

Time frame
Time Frame: 12 months: Baseline, Daily (0 to 4 weeks), monthly (5 to 52 weeks)

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