NCT06900439

Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: Zoe Global Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

PREDICT REFINE is a sub-study of PREDICT 3 with the primary aim of exploring glycemic responses through continuous glucose monitoring in a healthy population. The study will explore glycemic responses to a standardised test meal before and after a personalised dietary programme. The sub-study will include wearing a Continuous Glucose Monitor for 14 days, collecting information around diet and health, providing a stool sample, and consuming a standardised test meal. By conducting this study researchers hope to better understand Continuous Glucose Monitoring accuracy and variability in healthy individuals, the impact of diet on glycemic responses over time, and potential mechanisms by which changes in microbiome health may influence glycemic control.

Detailed description

PREDICT REFINE is a single-arm mechanistic intervention study designed as a sub-study of PREDICT 3. The primary objective is to explore glycemic responses through continuous glucose monitoring (CGM) in a healthy population, specifically examining responses to a standardized test meal before and after a personalised dietary programme. Study Population and Recruitment: The study population consists of individuals who have previously enrolled in the commercial ZOE testing program, consented to participate in the PREDICT 3 study, and provided consent for scientific research at ZOE. Prospective participants will be selected based on predefined inclusion and exclusion criteria by the study management team. Recruitment will be conducted via email, with potential participants receiving a Participant Information Sheet. A minimum of 24 hours will be provided for individuals to consider participation. Those interested will complete an online screening form via a secure survey platform, and eligible participants will be asked to provide informed consent. Study Design and Procedures: Following informed consent, participants will undergo the following study tasks in a 14 day timeframe: 1. Continuous Glucose Monitoring: Participants will wear a CGM device for 14 days to record continuous data on blood glucose responses. 2. Data Collection: Participants will be required to provide comprehensive information about their diet and health during the study period. This will include completing food logs, a food frequency questionnaire, and a health + lifestyle questionnaire on a mobile app. 3. Biological Sample Collection: Participants will provide a stool sample, which will be analyzed using metagenomic sequencing. 4. Consume a Standardized Test Meal: Participants will consume a standardized test meal under controlled conditions. As participants will be recruited from the PREDICT 3 study, the above tasks would have been completed at baseline, \~4 months prior to the start of the sub study while participating in PREDICT 3. Study consent will allow baseline and endpoint data (collected as part of this sub-study) to be connected.

Conditions

• Gut Microbiome
• Glucose Control

Interventions

Type	Name	Description
OTHER	Dietary Intervention	To carry out a dietary intervention using a standardized test meal where the participant's postprandial glucose to the meal is measured with a continuous glucose monitor and compared to the participant's postprandial glucose from the same standardized test meal 4 months prior.

Timeline

• Start date: 2025-03-21
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2025-03-28
• Last updated: 2025-09-08

Locations

1 site across 1 country: United Kingdom