An interventional study of Dietary Intervention in Diabetes, Heart Diseases and Diet Habit, sponsored by Zoe Global Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Zoe Global Limited · Not applicable, Interventional, and Basic science
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.
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:
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 1,139 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Zoe Global Limited is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Dietary intervention using standardised test meals, on up to 8 days within the study period.
Other: Dietary Intervention
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.
Gut microbiome species richness
Species count in fecal sample
Time frame: 1 Day
Lipids
Measurement of blood lipids
Time frame: 3 days
Glucose
Measurement of blood glucose
Time frame: 11 days
Sleep
Record of sleep pattern using a wearable device (i.e. fitness watch)
Time frame: 10 days
Physical activity
Record of physical activity using a wearable device (i.e. fitness watch)
Time frame: 10 days
Hunger and appetite assessment
Record of hunger and appetite patterns using a digital app
Time frame: 10 days
Glucose metabolism
C-peptide
Time frame: 3 days
Dietary assessment
Weighed food log
Time frame: 10 days
Anthropometry
Weight (kg)
Time frame: 1 day
Anthropometry
Height (cm)
Time frame: 1 day
Anthropometry
Hip and waist circumference (cm)
Time frame: 1 day
Metabolomics by NMR analysis
Lipoprotein concentration (mol/L), lipoprotein composition (mol/L), glycoprotein acetyl concentration (mol/L), ketone bodies concentration (mol/L)
Time frame: 1 day
Dietary assessment
Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.
Time frame: 1 month
Covid-19 symptom assessment
Self-reported demographic and physical health symptoms, or lack thereof, reported on a daily basis.
Time frame: 6 months
Adherence (in sub-cohort)
Self-reported in-app question on daily frequency of adherence (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Hunger (in sub-cohort)
Self-reported in-app question on hunger levels (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Weight (in sub-cohort)
Self-reported in-app question on weight (lbs)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Bristol Stool Category (in sub-cohort)
Self-reported in-app Bristol Stool chart questoin (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Bowel Frequency (in sub-cohort)
Self-reported in-app question on bowel frequency
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Energy (in sub-cohort)
Self-reported in-app question on energy levels (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Alertness (in sub-cohort)
Self-reported in-app question on alertness (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Stress (in sub-cohort)
Self-reported in-app question on stress (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Mood (in sub-cohort)
Self-reported in-app question on mood (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Activity (in sub-cohort)
Self-reported in-app question on daily frequency of activity (categorical)
Time frame: 12 months: Baseline, Weekly (0 to 4 weeks), monthly (5 to 24 weeks), 36 weeks, 52 weeks
Dietary assessment
Diet history and portion size questionnaire about the preceding month, using the Diet History Questionnaire 3 from National Cancer Institute.
Time frame: 12 months: 24 weeks, 52 weeks
Gut microbiome species richness
Species count in fecal sample
Time frame: 12 months: 24 weeks, 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Mar 2020, 9 months.
Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 9 months is below that.
Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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