Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04735835

Personalized Responses to Dietary Composition Trial 3 A Study Using Standardized Meals and Digital Monitoring to Understand Individual Food Responses

Led by Zoe Global Limited · Updated on 2025-04-16

250000

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

Z

Zoe Global Limited

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are building on previous studies involving over 2,000 people to improve machine learning models that predict how individuals respond to different foods. The goal is to advance precision nutrition science and provide personalized dietary advice. This study uses both controlled dietary tests and free-living periods to observe responses to various meals and factors like exercise, sleep, and time of day. It also incorporates a commercial product to reach many participants who collect data through digital and biochemical devices. Participants will take part for 6 to 14 days. On the first day, they will wear a continuous glucose monitor on their arm. They will then eat two standardized meals each day, provided by the study team, and track their food intake using a digital app. After this period, participants can eat freely but must continue logging all meals, snacks, drinks, sleep, physical activity, mood, hunger, and medication use on the app. The study includes use of wearable devices and collection of blood and stool samples among users of the commercial product. Participants will complete questionnaires about their diet, lifestyle, and psychological state before and during the study. Continuous glucose levels will be monitored every 5 minutes during the intervention. Regular contact via phone, app, and messages will support compliance. Some participants may join a follow-up study to try dietary advice from the app for up to a year, reporting weight, bowel habits, hunger, energy, and app usage. The study measures glucose, gut microbiome diversity, blood lipids, hunger, and other health indicators throughout the study period.

CONDITIONS

Brief Title

Personalized Responses to Dietary Composition Trial 3

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Enrolled in the commercial ZOE testing program
  • Any sex
  • At least 18 years old (19 years in Alabama and Nebraska due to state laws)
  • Body mass index (BMI) of 16.5 kg/m2 or higher
  • Living in continental US states (excluding New York) or in the UK
  • Able and willing to follow the study protocol and give informed consent
  • Under medical care for chronic conditions and have confirmed safety with their primary doctor (US participants only)
Not Eligible

You will not qualify if you...

  • Unable or unwilling to safely eat the standardized test meals due to allergies or recent gastrointestinal surgery
  • Currently pregnant
  • Had a heart attack, stroke, or major surgery within the last two months
  • Unable to read and write in English, since the study app is only in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Dietary Intervention

Duration - 6 to 14 days

Participants undergo a dietary intervention where they consume standardized test meals over several days while wearing a continuous glucose monitor. They record all food intake, physical activity, and psychological data using a digital app and a wearable device, with regular contact from the study team to support compliance.

Daily digital app entries and device use; 1 device fitting visit (in-person or remote)

Follow-up Monitoring

Duration - Up to 12 months

Participants optionally continue monitoring their diet, weight, bowel habits, and other health measures for up to 12 months while following dietary guidance from the study app. Stool samples may be collected at variable intervals for some participants.

Monthly remote assessments and self-reporting via app

Trial Site Locations

Total: 2 locations

1

Zoe US Inc.

Needham, Massachusetts, United States, 02494

Actively Recruiting

2

King's College London

London, United Kingdom

Actively Recruiting

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Research Team

M

Meaghan Reardon

D

Dan Sleeper

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Frequently Asked Questions

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