Gut MicrobiomeNCT06900439
Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population
A study testing Dietary Intervention in people with Gut Microbiome and Glucose Control, run by Zoe Global Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Glucose Control
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Continuous Glucose Monitoring: Participants will wear a CGM device for 14 days to record continuous data on blood glucose responses.
- 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.
- Biological Sample Collection: Participants will provide a stool sample, which will be analyzed using metagenomic sequencing.
- 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
- Being tested
- Dietary Intervention
- Keywords
- CGM, Continuous Glucose Monitor, Glucose, Gut Microbiome, Healthy Population, Glycemic Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Dietary intervention using a standardized test meal after which the postprandial glucose response is measured. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemic Control
Measurement of glycaemic control with a continuous glucose monitor (CGM).
Measured: Baseline and Month 4
Secondary outcomes (2)
Gut Microbiome Composition
The measurement of relative abundance of microbiome species, derived from metagenomic analysis of stool samples.
Measured: Baseline and Month 4
Gut Microbiome Diversity
The measurement of diversity metrics (e.g. richness, evenness, ranking of species associated with diet and health) derived from metagenomic analysis of stool samples.
Measured: Baseline and Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start21 Mar 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm mechanistic intervention study
- Masking
- None (open label)
- Enrolment
- 1,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoe Global Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900439
- Sponsor's protocol ID
- ZOE PREDICT REFINE
- Status last verified
- Aug 2025
- First submitted
- 21 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population
- ClinicalTrials.gov ID
- NCT06900439
- Acronym / sponsor ID
- ZOE PREDICT REFINE
- Conditions
- Gut Microbiome, Glucose Control
- Keywords
- CGM, Continuous Glucose Monitor, Glucose, Gut Microbiome, Healthy Population, Glycemic Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- Zoe Global LimitedUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Continuous Glucose Monitoring: Participants will wear a CGM device for 14 days to record continuous data on blood glucose responses.
- 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.
- Biological Sample Collection: Participants will provide a stool sample, which will be analyzed using metagenomic sequencing.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm mechanistic intervention study
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: Dietary InterventionDietary intervention using a standardized test meal after which the postprandial glucose response is measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary InterventionTo 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. | Other | Dietary Intervention |
Primary outcome
Glycaemic Control
Time frame: Baseline and Month 4
Measurement of glycaemic control with a continuous glucose monitor (CGM).
2 secondary outcomes
Gut Microbiome Composition
Time frame: Baseline and Month 4
Gut Microbiome Diversity
Time frame: Baseline and Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Gut Microbiome
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Gut Microbiome and Glucose Control, run by Zoe Global Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemic Control (time frame: Baseline and Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.