Clinical trial

Personalized Responses to Dietary Composition Trial 3

Recruiting now · Not applicable · 2 countries · Registry ID NCT04735835

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionDiabetes, Heart Diseases, Diet Habit, Diet Modification, Healthy, Obesity, Metabolism, Microbial Colonization

Full registry 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.

Treatments and study arms

Dietary Intervention

Other

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.

Primary outcomes

Glucose6-14 days

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

Gut microbiome species richness1 day

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

Blood Lipids1 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 assessment6-14 days

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

Glucose and HbA1c2 days

Measurement of baseline glucose (mmol/L) and HbA1c (%) by dried blood sample (as part of ZOE testing program)

Study locations

2 locations were listed when this page was built. The first 40 are shown.

King's College London🇬🇧 London, United Kingdom

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Inbar LinenbergContact

Sarah BerryContact

Sarah E Berry, PhDPrincipal Investigator

Zoe US Inc.🇺🇸 Needham, Massachusetts, United States

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Brad ReardonContact

Email · Call +1866-771-7478