DiabetesNCT03983733
PREDICT 2: Personalized Responses to Dietary Composition Trial 2
A study testing Dietary Intervention in people with Diabetes and Heart Diseases, run by Zoe Global Limited at 1 site in United States.
Trial summary
Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Heart Diseases, Diet Habit
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,139 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 1 Dec 2021
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- 18-70 years of age (19 year age minimum in Alabama and Nebraska)
- Body mass index (BMI) between 16.5 and 49.9 kg/m2.
- Living in the continental USA.
- Able and willing to comply with the study protocol and provide informed consent.
Who cannot join
- Refuse or are unable to provide informed consent to participate in the study.
- Have ongoing, active inflammatory disease or condition e.g. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
- Have had cancer in the last two years, excluding skin cancer.
- Have been diagnosed with Inflammatory Bowel Disease (ulcerative colitis and Crohn's disease) or Celiac disease (gluten allergy), or any other long-term gastrointestinal disorder that would prevent the individual from safely eating normal US food. Irritable Bowel Syndrome is not an exclusion.
- Have had bariatric or other major gastrointestinal surgery.
- Have been medically advised that eating high-fat meals over a period of a few days might be dangerous.
Show all 25Show fewer
- Currently suffer from severe anemia or jaundice.
- Have taken any of the following medications in the last three months:
- immunosuppressants (including oral steroids) or antiretroviral therapies or antibiotics (excluding topical antibiotics). If diagnosed with non-alcoholic fatty liver disease, use of any steatogenic medications (amiodarone or methotrexate) or insulin in the last 3 months
- Have an uncontrolled intercurrent illness (e.g. hepatitis c, influenza)
- Are using proton pump inhibitors ("PPI"s such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and abstain from use during the study.
- Have type 1 diabetes.
- Have type 2 diabetes and are taking insulin or sulfonyurea medications (such as Diamicron (Gliclazide), Diamicron MR (Gliclazide), Amaryl (Glimepiride), Daonil (Gilbenclamide or Glyburide), Gibenese (Glipizide), Minodiab (Glipizide), Tolbutamide (Tolbutamide)). For clarity, people with type 2 diabetes can participate if they take metformin or gliptins.
- Have type 2 diabetes and a fasting glucose level of >216mg/dL. These individuals wil be excluded whether or not they are on medication.
- Started antidepressant medication within the last 3 months, or are currently suffering from acute clinically diagnosed depression which is not well controlled.
- Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
- Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months.
- Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa)
- Are vegan, or unwilling to consume foods that are part of the study.
- Do not have a mobile phone capable of running the Zoe study/results apps, or are unable to use their phone to operate the apps. As a consequence of this exclusion, all participants must be able to read and write in English, as the app is only available in English.
- Are unable to have continuous access to their smartphone or unable to wear the activity tracker on their arm for the duration of the study, e.g. because their work will not allow it.
- Have a known allergy to adhesives like that used to affix the continuous glucose monitor.
- Are unable or unwilling to visit a Quest center to provide fasting blood samples.
- Do not have access to wifi or unlimited mobile data to allow them to download the app for free and upload data during the study.
- Do not have a freezer to store study-related foods required for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways.
Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease.
Read more
The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome.
The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.
Read the detailed description
Choice of design: The study is a single arm mechanistic intervention study.
Study population: Participants will be recruited through online and offline advertisements, and through health professionals.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Screening will be online and via phone. Prospective participants will be booked in to start their study period and will receive a study kit by post.
Study duration: Each participant will take part in the study for a period of up to 12 days.
Dietary intervention: The dietary intervention will be carried out on up to 8 days within the 12-day study period. On day one, participants will be asked to collect biological samples and fit wearable devices (glucose monitor and physical activity tracker). Over the following consecutive days, each participant will be instructed to eat up to 8 standardised meals for breakfast, which must be their first meal of the day. On up to 3 of the days the participants will also be asked to eat a standardised lunch. Participants are free to eat whatever they wish at all other times. The standardised meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be reassured that the amount of food will be designed to ensure a stable body weight over the course of the study. Participants will be asked to consume the entire amount of food indicated for the standardised meals and to record any left-over food via a digital app for which training will be provided at the start of the study. Following completion of standardised meal days, participants are free to eat and drink whatever they wish and will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study. The 12th day of the study involves a visit to a medical clinic where participants will provide a fasted blood sample.
Regular contact will be made with the participants via phone, their app and text messages for the period of the intervention to encourage compliance and answer any queries.
Anthropometry: The participant will be instructed to measure their weight, height, waist and hip circumference.
Dietary and Lifestyle: Participants will be asked to complete a baseline questionnaire online, as well as a diet history questionnaire with portion sizes about the month preceding their study period. They will be asked to record on a daily basis their dietary, activity, and psychological data (e.g. hunger) using a digital mobile phone app. Lifestyle information (such as sleep and exercise) will be monitored using digital wearable devices. Training in all apps and equipment will be given through written and online instructions and via communications with the study support staff.
Digital devices: Participants will be asked to record daily dietary and activity information using digital apps and lifestyle information will be monitored using digital wearable devices. The continuous glucose monitor (Freestyle Libre, CGM) provides continuous glucose profiles for up to 14 days. The CGM will be inserted on the back of the upper arm, one day before participants begin dietary intervention. This will measure subcutaneous interstitial fluid glucose concentrations every 5 minutes. The CGM will be removed at the end of the intervention period by the participant. A contact number will be made available to participants for any inquiries or if any problems arise. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected.
Blood samples: The participant will collect postprandial blood on 2 days using finger-prick blood sampling. They will also provide a fasted blood sample after the study period to measure their baseline metabolomic profile.
Digital app: Participants will be asked to download an app designed specifically for this study, which provides diet \& activity logging functionality similar to widely used existing apps such as MyFitnessPal.
Participants will be asked to record and monitor the following information via the digital app and wearable devices, on a daily basis:
- All food and drink they consume, with serving sizes and photos
- Sleep and physical activity patterns, including exercise
- Hunger and alertness ratings
- Psychological feeling of energy and mood
- Prescription and over-the-counter drug consumption
The app will be available in versions for both iOS and Android operating systems, and will support a wide range of mobile phone models as expected across the participant population. The app will synchronise remotely with backend database servers, over an encrypted and authenticated API, and will support offline operation for when patients wish to record an entry without network coverage. This continuous background synchronization means that it will not be necessary to explicitly download data from the phone at the end of the study.
Following the 2020 pandemic of COVID-19, participants are asked to use the COVID-19 Symptom Tracker app to record their physical health symptoms, or lack thereof, attributable to COVID-19, as well as demographic and other health information to track the spread of disease in real time, and to potentially reveal risk factors for infection and severe illness.
Subcohort: An opt-in follow-on study will be offered to participants to follow dietary guidance from the ZOE app based on their Predict 2 results. During the first 2 to 4 weeks, participants will be given dietary guidance to follow from the ZOE app. Thereafter, for a period of up to 12 months, participants will be asked to report on outcome measures at regular intervals (monthly). Outcome measures will be reported before, during and after the 2 to 4 week period and include weight, bristol stool, bowel habits, hunger, energy, alertness, stress, mood, activity, adherence to dietary advice, and app usage.
The data will be used to test the efficacy of the ZOE dietary advice in promoting weight loss and improvement of overall health, and may be stratified by age, sex, BMI, adherence and/or motivation to take part in the PREDICT 2 study.
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Microbial Colonization, Healthy
- Being tested
- Dietary Intervention
- Keywords
- Gut microbiome, Personalised Nutrition, Metabolic health, Postprandial metabolism
- Medical subject headings
- Diabetes Mellitus, Heart Diseases, Feeding Behavior, Communicable Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
To carry out an interventional dietary study using standardised meals to predict an individual's metabolic response to certain foods, using their gut microbiome, metabolic profile, and other measurable characteristics such as weight, sleep and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Dietary intervention using standardised test meals, on up to 8 days within the study period. Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome species richness
Species count in fecal sample
Measured: 1 Day
Lipids
Measurement of blood lipids
Measured: 3 days
Glucose
Measurement of blood glucose
Measured: 11 days
Sleep
Record of sleep pattern using a wearable device (i.e. fitness watch)
Measured: 10 days
Physical activity
Record of physical activity using a wearable device (i.e. fitness watch)
Measured: 10 days
Hunger and appetite assessment
Record of hunger and appetite patterns using a digital app
Measured: 10 days
Secondary outcomes (8)
Glucose metabolism
C-peptide
Measured: 3 days
Dietary assessment
Weighed food log
Measured: 10 days
Anthropometry
Weight (kg)
Measured: 1 day
Anthropometry
Height (cm)
Measured: 1 day
Anthropometry
Hip and waist circumference (cm)
Measured: 1 day
Metabolomics by NMR analysis
Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)
Measured: 1 day
Dietary assessment
Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.
Measured: 1 month
Covid-19 symptom assessment
Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start10 Jun 2019
- Primary completion31 Mar 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoe Global Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, King's College London, Tufts University
- Responsible party
- Sponsor
- Investigators
- Tim Spector, Pr., Principal investigator, Zoe Global Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983733
- Sponsor's protocol ID
- PREDICT 2
- Status last verified
- Jan 2022
- First submitted
- 7 Jun 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT 2: Personalized Responses to Dietary Composition Trial 2
- ClinicalTrials.gov ID
- NCT03983733
- Acronym / sponsor ID
- PREDICT 2
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Microbial Colonization, Healthy
- Keywords
- Gut microbiome, Personalised Nutrition, Metabolic health, Postprandial metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- Zoe Global LimitedUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Stanford University, King's College London, Tufts University
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Jun 2019 (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.
Foods in the human diet can affect the development of diseases over time, such as diabetes or heart disease. This is because the amount and types of foods in the diet eat can affect a person's weight, and because different foods are metabolised (processed) by the body in different ways.
Scientists have also found that the bacteria in the human gut (the gut microbiome) affect their metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect the levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often for too long, there is a greater chance of developing diseases such as diabetes and cardiovascular disease.
The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in the human gut are found in everyone. This might mean that the best diet to prevent disease needs matching to a person's gut microbiome and it might be possible to find personalised foods or diets that will help reduce the chance of developing chronic disease as well as metabolic syndrome.
The study investigators are recruiting volunteers aged 18-70 years to take part in a study that aims to answer the questions above. Participants will be asked to consume standardised meals on up to 8 days while wearing glucose monitors (Abbott Freestyle Libre) to measure their blood sugar levels. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record their appetite, food, physical activity and sleep using apps and wearable devices. They will be asked to collect a fecal and saliva sample before consuming the standardised meals, and to provide a fasted blood sample at the end of the study period.
Detailed description
Choice of design: The study is a single arm mechanistic intervention study.
Study population: Participants will be recruited through online and offline advertisements, and through health professionals.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Screening will be online and via phone. Prospective participants will be booked in to start their study period and will receive a study kit by post.
Study duration: Each participant will take part in the study for a period of up to 12 days.
Dietary intervention: The dietary intervention will be carried out on up to 8 days within the 12-day study period. On day one, participants will be asked to collect biological samples and fit wearable devices (glucose monitor and physical activity tracker). Over the following consecutive days, each participant will be instructed to eat up to 8 standardised meals for breakfast, which must be their first meal of the day. On up to 3 of the days the participants will also be asked to eat a standardised lunch. Participants are free to eat whatever they wish at all other times. The standardised meals will be provided to all participants by the study team via post. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in US supermarkets. Participants will be reassured that the amount of food will be designed to ensure a stable body weight over the course of the study. Participants will be asked to consume the entire amount of food indicated for the standardised meals and to record any left-over food via a digital app for which training will be provided at the start of the study. Following completion of standardised meal days, participants are free to eat and drink whatever they wish and will be asked to track all meals, snacks and drinks on their digital app. Participants will also be advised not to change their physical activity patterns during the course of the study. The 12th day of the study involves a visit to a medical clinic where participants will provide a fasted blood sample.
Regular contact will be made with the participants via phone, their app and text messages for the period of the intervention to encourage compliance and answer any queries.
Anthropometry: The participant will be instructed to measure their weight, height, waist and hip circumference.
Dietary and Lifestyle: Participants will be asked to complete a baseline questionnaire online, as well as a diet history questionnaire with portion sizes about the month preceding their study period. They will be asked to record on a daily basis their dietary, activity, and psychological data (e.g. hunger) using a digital mobile phone app. Lifestyle information (such as sleep and exercise) will be monitored using digital wearable devices. Training in all apps and equipment will be given through written and online instructions and via communications with the study support staff.
Digital devices: Participants will be asked to record daily dietary and activity information using digital apps and lifestyle information will be monitored using digital wearable devices. The continuous glucose monitor (Freestyle Libre, CGM) provides continuous glucose profiles for up to 14 days. The CGM will be inserted on the back of the upper arm, one day before participants begin dietary intervention. This will measure subcutaneous interstitial fluid glucose concentrations every 5 minutes. The CGM will be removed at the end of the intervention period by the participant. A contact number will be made available to participants for any inquiries or if any problems arise. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected.
Blood samples: The participant will collect postprandial blood on 2 days using finger-prick blood sampling. They will also provide a fasted blood sample after the study period to measure their baseline metabolomic profile.
Digital app: Participants will be asked to download an app designed specifically for this study, which provides diet \& activity logging functionality similar to widely used existing apps such as MyFitnessPal.
Participants will be asked to record and monitor the following information via the digital app and wearable devices, on a daily basis:
- All food and drink they consume, with serving sizes and photos
- Sleep and physical activity patterns, including exercise
- Hunger and alertness ratings
- Psychological feeling of energy and mood
- Prescription and over-the-counter drug consumption
The app will be available in versions for both iOS and Android operating systems, and will support a wide range of mobile phone models as expected across the participant population. The app will synchronise remotely with backend database servers, over an encrypted and authenticated API, and will support offline operation for when patients wish to record an entry without network coverage. This continuous background synchronization means that it will not be necessary to explicitly download data from the phone at the end of the study.
Following the 2020 pandemic of COVID-19, participants are asked to use the COVID-19 Symptom Tracker app to record their physical health symptoms, or lack thereof, attributable to COVID-19, as well as demographic and other health information to track the spread of disease in real time, and to potentially reveal risk factors for infection and severe illness.
Subcohort: An opt-in follow-on study will be offered to participants to follow dietary guidance from the ZOE app based on their Predict 2 results. During the first 2 to 4 weeks, participants will be given dietary guidance to follow from the ZOE app. Thereafter, for a period of up to 12 months, participants will be asked to report on outcome measures at regular intervals (monthly). Outcome measures will be reported before, during and after the 2 to 4 week period and include weight, bristol stool, bowel habits, hunger, energy, alertness, stress, mood, activity, adherence to dietary advice, and app usage.
The data will be used to test the efficacy of the ZOE dietary advice in promoting weight loss and improvement of overall health, and may be stratified by age, sex, BMI, adherence and/or motivation to take part in the PREDICT 2 study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: Dietary InterventionDietary intervention using standardised test meals, on up to 8 days within the study period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- 18-70 years of age (19 year age minimum in Alabama and Nebraska)
- Body mass index (BMI) between 16.5 and 49.9 kg/m2.
- Living in the continental USA.
- Able and willing to comply with the study protocol and provide informed consent.
Key exclusion criteria (25 listed)
- Refuse or are unable to provide informed consent to participate in the study.
- Have ongoing, active inflammatory disease or condition e.g. Rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
- Have had cancer in the last two years, excluding skin cancer.
- Have been diagnosed with Inflammatory Bowel Disease (ulcerative colitis and Crohn's disease) or Celiac disease (gluten allergy), or any other long-term gastrointestinal disorder that would prevent the individual from safely eating normal US food. Irritable Bowel Syndrome is not an exclusion.
- Have had bariatric or other major gastrointestinal surgery.
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 an interventional dietary study using standardised meals to predict an individual's metabolic response to certain foods, using their gut microbiome, metabolic profile, and other measurable characteristics such as weight, sleep and exercise. | Other | Dietary Intervention |
Primary outcome
Gut microbiome species richness
Time frame: 1 Day
Species count in fecal sample
Lipids
Time frame: 3 days
Measurement of blood lipids
Glucose
Time frame: 11 days
Measurement of blood glucose
Sleep
Time frame: 10 days
Record of sleep pattern using a wearable device (i.e. fitness watch)
Physical activity
Time frame: 10 days
Record of physical activity using a wearable device (i.e. fitness watch)
Hunger and appetite assessment
Time frame: 10 days
Record of hunger and appetite patterns using a digital app
8 secondary outcomes
Glucose metabolism
Time frame: 3 days
Dietary assessment
Time frame: 10 days
Anthropometry
Time frame: 1 day
Anthropometry
Time frame: 1 day
Anthropometry
Time frame: 1 day
Metabolomics by NMR analysis
Time frame: 1 day
Dietary assessment
Time frame: 1 month
Covid-19 symptom assessment
Time frame: 6 months
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 18 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
Tim Spector, Pr. principal investigator
Zoe Global Limited
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 Diabetes and Heart Diseases, run by Zoe Global Limited at 1 site in United States.
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 5 inclusion and 25 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 18 Jan 2022. 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 States. 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?
Gut microbiome species richness (time frame: 1 Day). The study lists 6 primary outcomes in all. 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 18 Jan 2022.