Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population

NCT06900439 | Completed

• 1 other identifier: ZOE PREDICT REFINE
• Study Type: interventional
• Target: 1,189
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gut Microbiome; Glucose Control

Keywords

CGM; Continuous Glucose Monitor; Glucose; Gut Microbiome; Healthy Population; Glycemic Response

Outcome Measures

Primary Outcomes (1)

• Glycaemic Control

  Measurement of glycaemic control with a continuous glucose monitor (CGM).

  Baseline and Month 4

Secondary Outcomes (2)

• Gut Microbiome Composition

  Baseline and Month 4

• Gut Microbiome Diversity

  Baseline and Month 4

Other Outcomes (1)

• Dietary Intake

  Baseline and Month 4

Study Arms (1)

Dietary Intervention

EXPERIMENTAL

Dietary intervention using a standardized test meal after which the postprandial glucose response is measured.

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

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.

Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the ZOE product \& purchased a Gut Health Retest at month 4
• Any sex
• Minimum 18 years of age
• Body mass index (BMI) greater than or equal to 18.5 kg/m2

You may not qualify if:

• Able and willing to comply with the study protocol and provide informed consent before your ZOE Gut Health Retest is fulfilled and posted.
• Live in the United Kingdom
• Cannot safely eat the standardised meals (part of the ZOE product) which contain standard UK ingredients, e.g. due to allergy or recent gastrointestinal surgery
• Cannot safely use the cgm (per manufacturer's contraindications for use including critically ill, pregnant, receiving dialysis, or have an implantable medical device)
• 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.
• Are diagnosed with type 1 diabetes and/or require the use of exogenous insulin or oral hypoglycaemic medications to regulate blood sugar levels
• Have an active eating disorder (e.g. anorexia nervosa or bulimia nervosa)
• Have an active gut or digestive system disease (e.g. IBD, Crohn's disease or ulcerative colitis)
• Are undergoing chemotherapy treatment for cancer
• Unable to complete study tasks by 31 May 2025

Sponsors & Collaborators

• Zoe Global Limited: lead

Study Sites (1)

ZOE Limited

London, SE17RW, United Kingdom

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm mechanistic intervention study

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: March 21, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)