Recruiting

Dietary Composition

Sponsor:

Zoe Global Limited

Code:

NCT04735835

Conditions

Diabetes

Heart Diseases

Diet Habit

Diet Modification

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dietary Intervention

Study Details

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.

Conditions

Diabetes

Heart Diseases

Diet Habit

Diet Modification

Healthy

Study ID

NCT04735835

Start date

Jul 20, 2020

Status verified date

Apr, 2025

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

250000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Dietary Intervention

Dietary intervention using standardized test meals after which the postprandial metabolic response is measured.

Interventions

Dietary 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.

Primary outcome measure

  • Glucose [ Time Frame: 6-14 days ]
  • Gut microbiome species richness [ Time Frame: 1 day ]
  • Blood Lipids [ Time Frame: 1 day ]
  • Hunger and appetite assessment [ Time Frame: 6-14 days ]
  • Glucose and HbA1c [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Meaghan Reardon

866-771-7478meaghan@joinzoe.com

Dan Sleeper

866-771-7478dan@joinzoe.com

Locations

Zoe US Inc.

Recruiting

Needham, Massachusetts, United States, 02494

Contacts

Brad Reardon

+1866-771-7478hello@joinzoe.com

More Information

Sponsor

Zoe Global Limited

Last update posted

Apr 16, 2025

Last verified

Apr, 2025

Keywords

  • Gut microbiome
  • Personalised nutrition
  • Machine learning
  • Postprandial metabolism
  • Metabolic health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zoe Global Limited on 2025-04-16.