Status:
COMPLETED
Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population
Lead Sponsor:
Zoe Global Limited
Conditions:
Gut Microbiome
Glucose Control
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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) i...
Eligibility Criteria
Inclusion
- 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
- If under care for any chronic medical conditions (including type 2 diabetes), you have confirmed with your treating physician that this sub study is safe for you. This does not apply to conditions listed in the exclusion criteria.
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2025
Estimated Enrollment :
1189 Patients enrolled
Trial Details
Trial ID
NCT06900439
Start Date
March 21 2025
End Date
May 31 2025
Last Update
September 8 2025
Active Locations (1)
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1
ZOE Limited
London, United Kingdom, SE17RW