Actively Recruiting
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
Eligibility Criteria
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)
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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)
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
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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