DiabetesPREDICTNCT03479866
Personalised Responses to Dietary Composition Trial
A study testing Dietary intervention in people with Diabetes and Heart Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our 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 years and olderHealthy 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
- 2,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2018to 4 May 2023
- 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
- Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 20 and 49.9 kg/m2.
- Eligibility within a subgroup of participants undergoing the home-based intervention (n=1,100) will require participants to be 18-65 years of age.
- Eligibility within a further subgroup of participants undergoing cardiometabolic phenotyping (n=50) will require participants to be >55 years of age.
Who cannot join
- Refuse or are unable to give informed consent to participate in the study
- Have ongoing inflammatory disease ie RA, SLE, polymyalgia and other connective tissue diseases.
- Have had cancer in the last three years, excluding skin cancer.
- Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy), but not including IBS.
- Are taking the following daily medications: immunosuppressants, antibiotics in the last three months.
- Are long-term users of PPIs (such as omeprazole and pantoprazole), unless they are able to stop two weeks before the start of the study and remain off them during the two weeks of the study.
Show all 18Show fewer
- Have type I diabetes mellitus or are taking medications for type II diabetes mellitus. Those not on medications but having a capillary glucose level of >12mmol/l based on HemoCue will be excluded. Screening blood results will be shared with their GP after the study.
- Are currently suffering from acute clinically diagnosed depression.
- Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
- Are pregnant
- Are vegan, suffering from an eating disorder or unwilling to take foods that are part of the study.
- For participants continuing onto the home-based intervention (n=2,000), the additional following exclusions apply:
- Do not have a mobile phone capable of running the digital app, or are unable to use it to operate the app.
- Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.
- For participants undergoing cardiometabolic phenotyping and XMRI (n=50), the additional following exclusions apply:
- Are <55 years of age
- Are not female
- Have any kind of non-removable materials on their person that are not permitted under MR imaging.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, England, SE1 7EH
Sarah Berry, 020 7848 4088, sarah.e.berry@kcl.ac.uk
About this study
Official title: Predicting Inter-individual Differences in Biochemical and Behavioral Response to Meals With Different Nutritional Compositions Using Metabolomic and Microbiome Profiling.
The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our weight, and because different foods are metabolised (processed) by the body in different ways.
Scientists have also found that the bacteria in our guts (the gut microbiome) affects our metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often, there's a greater chance of developing diseases such as diabetes.
Read more
The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in our guts 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 years or over from the TwinsUK cohort to take part in a study that aims to answer the questions above. The participants will need to come in for a clinical visit where they will give blood, stool, saliva and urine samples. The participants will also be given a standardised breakfast and lunch and fitted with a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. After the visit, the participants will be asked to eat standardised meals at home for breakfast for a further 12 days. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record constantly their appetite, food, physical activity and sleep using apps and wearable devices.
Read the detailed description
Choice of design: The study is a single arm mechanistic intervention study.
Study population: Twin participants will be recruited from the TwinsUK database and non-twins will be recruited via social media platforms and advertising campaigns.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements.
Study duration: Each participant will take part in the study for a period of up to 3 weeks.
The PREDICT study will be divided into 3 protocol cohorts, where all participants (n=2,500) complete a baseline clinical visit as described below. Of this total, Cohort 1 (n=1,150) will complete a home-based dietary intervention lasting up to 2 weeks (June 2018 - May 2019). Within this group, 100 participants will complete an additional home-based dietary intervention lasting up to 3 weeks (February 2019 - May 2019).
Following completion of this first cohort, Cohort 2 (n=900) will complete a similar home-based dietary intervention lasting up to 2 weeks (June 2019 - May 2023). Within this cohort, 50 participants will also complete deep cardiometabolic phenotyping at their clinical visit (September 2019 - February 2020).
Finally, Cohort 3 (n=450) will only complete the baseline clinical visit (June 2019 - May 2023).
Dietary intervention:
On day one (baseline visit) participants will be given standardised meals for breakfast and lunch. Participants continuing onto the home-based intervention (n=2,050) will receive a dietary intervention lasting up to 12 days following their clinical visit. Each participant will be instructed to eat standardised meals for breakfast, which must be their first meal of the day. On some of these days the participants will also be asked to eat a standardised lunch meal. Participants are free to eat whatever they wish at all other times, although we may provide a list of recommended foods. The standardised meals will be provided to all participants by the study team on the day of the visit. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in UK 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. For the remaining 2 days post the 12 day dietary intervention period, participants are free to eat and drink whatever they wish or choose from the list of recommended foods provided to them. They 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.
After the baseline visit, 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: Weight, height, waist and hip circumference, blood pressure, body fat will be taken using standard procedures, in duplicates by a trained researcher at all face to face appointments. DXA scans using a Hologic machine will be used to assess body composition in all participants.
Dietary and Lifestyle: Participants will be asked to complete a simple online baseline questionnaire plus record daily dietary and activity information using digital apps. Lifestyle information (such as sleep, exercise and heart rate) will be monitored using digital wearable devices. Dietary information and psychological data (eg hunger) will be recorded in a digital mobile phone app. Training in all apps and equipment will be given at the baseline visit.
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 at the baseline visit by a nurse. Subcutaneous interstitial fluid glucose concentrations are measured every 15 minutes by the CGM, and can be displayed on a remote device when necessary. The readings will be blinded so that the participant's behaviour is not affected by the glucose readings. The CGM will be removed at the end of the intervention period. Removal of the glucose monitor can be performed by the participants at home and detailed instructions on the removal procedure will be provided to them on day 1 of their visit. A 24-h contact number will be made available to participants for any inquiries or if any problems arose. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected on days 1-14.
Blood samples: Postprandial blood will be collected on day one in the clinic and on additional days at home using finger-prick blood sampling.
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:
- Daily record of foods eaten throughout the day with serving sizes and photographs
- Continuous sleep and physical activity patterns
- Periodical hunger, satiety and appetite ratings
- Psychological feeling of energy and mood
- Daily medication consumption
During their baseline visit day, participants will be assisted with installation and setup and provided with instructions on how to use the app. 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.
A subgroup of participants from Cohort 2 (n=50) who continue onto the home-phase will be recruited to provide additional cardiometabolic measures, based on previously collected metabolomic and phenotyping data. This subgroup will undergo an abdominal XMR scan and cardiovascular tests at their baseline visit, before continuing onto the home-based intervention.
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Microbial Colonization, Healthy
- Being tested
- Dietary intervention
- Keywords
- Gut microbiome, Personalised Nutrition, Metabolic health
- 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 for an individual their metabolic response to certain foods using the gut microbiome and their metabolic profile. Responses will include post-prandial appetite, levels of satiety, circulating glucose, insulin, ketone bodies and lipid levels.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | 2 week dietary intervention using standardized test meals Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome profile
Assessment of participants' gut microbiome
Measured: 1-2 days
Lipids
Measurement of blood lipids
Measured: 1 day to 2 weeks
Glucose
Measurement of blood Glucose
Measured: 2 weeks
Sleep
Record of sleep pattern using a wearable device (i.e. fitness watch)
Measured: 2 weeks
Physical activity
Record of physical activity using a wearable device (i.e. fitness watch)
Measured: 2 weeks
Hunger and appetite assessment
Record of hunger and appetite patterns using a digital app
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start4 Jun 2018
- Primary completion4 May 2023 (estimated)
- Study completion4 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Tim Spector, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479866
- Sponsor's protocol ID
- 236407
- Acronym
- PREDICT
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bermingham KM, May A, Asnicar F, Capdevila J, Leeming ER, Franks PW, Valdes AM, Wolf J, Hadjigeorgiou G, Delahanty LM, Segata N, Spector TD, Berry SE. Snack quality and snack timing are associated with cardiometabolic blood markers: the ZOE PREDICT study. Eur J Nutr. 2024 Feb;63(1):121-133. doi: 10.1007/s00394-023-03241-6. Epub 2023 Sep 15.
PubMed 37709944Bermingham KM, Stensrud S, Asnicar F, Valdes AM, Franks PW, Wolf J, Hadjigeorgiou G, Davies R, Spector TD, Segata N, Berry SE, Hall WL. Exploring the relationship between social jetlag with gut microbial composition, diet and cardiometabolic health, in the ZOE PREDICT 1 cohort. Eur J Nutr. 2023 Dec;62(8):3135-3147. doi: 10.1007/s00394-023-03204-x. Epub 2023 Aug 2.
PubMed 37528259Louca P, Berry SE, Bermingham K, Franks PW, Wolf J, Spector TD, Valdes AM, Chowienczyk P, Menni C. Postprandial Responses to a Standardised Meal in Hypertension: The Mediatory Role of Visceral Fat Mass. Nutrients. 2022 Oct 26;14(21):4499. doi: 10.3390/nu14214499.
PubMed 36364763Merino J, Linenberg I, Bermingham KM, Ganesh S, Bakker E, Delahanty LM, Chan AT, Capdevila Pujol J, Wolf J, Al Khatib H, Franks PW, Spector TD, Ordovas JM, Berry SE, Valdes AM. Validity of continuous glucose monitoring for categorizing glycemic responses to diet: implications for use in personalized nutrition. Am J Clin Nutr. 2022 Jun 7;115(6):1569-1576. doi: 10.1093/ajcn/nqac026.
PubMed 35134821Tsereteli N, Vallat R, Fernandez-Tajes J, Delahanty LM, Ordovas JM, Drew DA, Valdes AM, Segata N, Chan AT, Wolf J, Berry SE, Walker MP, Spector TD, Franks PW. Impact of insufficient sleep on dysregulated blood glucose control under standardised meal conditions. Diabetologia. 2022 Feb;65(2):356-365. doi: 10.1007/s00125-021-05608-y. Epub 2021 Nov 30.
PubMed 34845532Mazidi M, Valdes AM, Ordovas JM, Hall WL, Pujol JC, Wolf J, Hadjigeorgiou G, Segata N, Sattar N, Koivula R, Spector TD, Franks PW, Berry SE. Meal-induced inflammation: postprandial insights from the Personalised REsponses to DIetary Composition Trial (PREDICT) study in 1000 participants. Am J Clin Nutr. 2021 Sep 1;114(3):1028-1038. doi: 10.1093/ajcn/nqab132.
PubMed 34100082Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.
PubMed 33722860Menni C, Louca P, Berry SE, Vijay A, Astbury S, Leeming ER, Gibson R, Asnicar F, Piccinno G, Wolf J, Davies R, Mangino M, Segata N, Spector TD, Valdes AM. High intake of vegetables is linked to lower white blood cell profile and the effect is mediated by the gut microbiome. BMC Med. 2021 Feb 11;19(1):37. doi: 10.1186/s12916-021-01913-w.
PubMed 33568158Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.
PubMed 32528151
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Inter-individual Differences in Biochemical and Behavioral Response to Meals With Different Nutritional Compositions Using Metabolomic and Microbiome Profiling.
- ClinicalTrials.gov ID
- NCT03479866
- Acronym / sponsor ID
- PREDICT / 236407
- Conditions
- Diabetes, Heart Diseases, Diet Habit, Diet Modification, Microbial Colonization, Healthy
- Keywords
- Gut microbiome, Personalised Nutrition, Metabolic health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Massachusetts General Hospital
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 4 May 2023 (estimated)
- Study completion
- 4 May 2023 (estimated)
- First posted
- 27 Mar 2018 (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.
The foods we eat - our diet - can affect whether we develop diseases during our lives, such as diabetes or heart disease. This is because the amount and types of foods we eat can affect our weight, and because different foods are metabolised (processed) by the body in different ways.
Scientists have also found that the bacteria in our guts (the gut microbiome) affects our metabolism, weight and health and that, together with a person's diet and metabolism, could be used to predict appetite and how meals affect levels of sugar (glucose) and fats (lipids) found in blood after eating. If blood sugar and fat are too high too often, there's a greater chance of developing diseases such as diabetes.
The gut microbiome is different in different people. Only 10-20% of the types of bacteria found in our guts 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 years or over from the TwinsUK cohort to take part in a study that aims to answer the questions above. The participants will need to come in for a clinical visit where they will give blood, stool, saliva and urine samples. The participants will also be given a standardised breakfast and lunch and fitted with a glucose monitor (Abbott Freestyle Libre-CE marked) to monitor their blood sugar levels. After the visit, the participants will be asked to eat standardised meals at home for breakfast for a further 12 days. Participants will also be required to prick their fingers at regular intervals to collect small amounts of blood, and to record constantly their appetite, food, physical activity and sleep using apps and wearable devices.
Detailed description
Choice of design: The study is a single arm mechanistic intervention study.
Study population: Twin participants will be recruited from the TwinsUK database and non-twins will be recruited via social media platforms and advertising campaigns.
Screening Assessment: Prospective participants will be selected based on the defined inclusion and exclusion criteria by the study management team. Recruitment will be done over the phone and via the Internet and emails and prospective participants will be booked in for their initial appointment to acquire baseline measurements.
Study duration: Each participant will take part in the study for a period of up to 3 weeks.
The PREDICT study will be divided into 3 protocol cohorts, where all participants (n=2,500) complete a baseline clinical visit as described below. Of this total, Cohort 1 (n=1,150) will complete a home-based dietary intervention lasting up to 2 weeks (June 2018 - May 2019). Within this group, 100 participants will complete an additional home-based dietary intervention lasting up to 3 weeks (February 2019 - May 2019).
Following completion of this first cohort, Cohort 2 (n=900) will complete a similar home-based dietary intervention lasting up to 2 weeks (June 2019 - May 2023). Within this cohort, 50 participants will also complete deep cardiometabolic phenotyping at their clinical visit (September 2019 - February 2020).
Finally, Cohort 3 (n=450) will only complete the baseline clinical visit (June 2019 - May 2023).
Dietary intervention:
On day one (baseline visit) participants will be given standardised meals for breakfast and lunch. Participants continuing onto the home-based intervention (n=2,050) will receive a dietary intervention lasting up to 12 days following their clinical visit. Each participant will be instructed to eat standardised meals for breakfast, which must be their first meal of the day. On some of these days the participants will also be asked to eat a standardised lunch meal. Participants are free to eat whatever they wish at all other times, although we may provide a list of recommended foods. The standardised meals will be provided to all participants by the study team on the day of the visit. The foods included as part of these meals will be foods that are commonly consumed and can be made from products sold in UK 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. For the remaining 2 days post the 12 day dietary intervention period, participants are free to eat and drink whatever they wish or choose from the list of recommended foods provided to them. They 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.
After the baseline visit, 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: Weight, height, waist and hip circumference, blood pressure, body fat will be taken using standard procedures, in duplicates by a trained researcher at all face to face appointments. DXA scans using a Hologic machine will be used to assess body composition in all participants.
Dietary and Lifestyle: Participants will be asked to complete a simple online baseline questionnaire plus record daily dietary and activity information using digital apps. Lifestyle information (such as sleep, exercise and heart rate) will be monitored using digital wearable devices. Dietary information and psychological data (eg hunger) will be recorded in a digital mobile phone app. Training in all apps and equipment will be given at the baseline visit.
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 at the baseline visit by a nurse. Subcutaneous interstitial fluid glucose concentrations are measured every 15 minutes by the CGM, and can be displayed on a remote device when necessary. The readings will be blinded so that the participant's behaviour is not affected by the glucose readings. The CGM will be removed at the end of the intervention period. Removal of the glucose monitor can be performed by the participants at home and detailed instructions on the removal procedure will be provided to them on day 1 of their visit. A 24-h contact number will be made available to participants for any inquiries or if any problems arose. Data from the CGM will be downloaded, and glucose profiles will be evaluated on the basis of data collected on days 1-14.
Blood samples: Postprandial blood will be collected on day one in the clinic and on additional days at home using finger-prick blood sampling.
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:
- Daily record of foods eaten throughout the day with serving sizes and photographs
- Continuous sleep and physical activity patterns
- Periodical hunger, satiety and appetite ratings
- Psychological feeling of energy and mood
- Daily medication consumption
During their baseline visit day, participants will be assisted with installation and setup and provided with instructions on how to use the app. 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.
A subgroup of participants from Cohort 2 (n=50) who continue onto the home-phase will be recruited to provide additional cardiometabolic measures, based on previously collected metabolomic and phenotyping data. This subgroup will undergo an abdominal XMR scan and cardiovascular tests at their baseline visit, before continuing onto the home-based intervention.
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 intervention2 week dietary intervention using standardized test meals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant eligibility includes those aged >18 years who have a body mass index (BMI) between 20 and 49.9 kg/m2.
- Eligibility within a subgroup of participants undergoing the home-based intervention (n=1,100) will require participants to be 18-65 years of age.
- Eligibility within a further subgroup of participants undergoing cardiometabolic phenotyping (n=50) will require participants to be >55 years of age.
Key exclusion criteria (18 listed)
- Refuse or are unable to give informed consent to participate in the study
- Have ongoing inflammatory disease ie RA, SLE, polymyalgia and other connective tissue diseases.
- Have had cancer in the last three years, excluding skin cancer.
- Have had long term gastrointestinal disorders including inflammatory bowel disease (IBD) or Coeliac disease (gluten allergy), but not including IBS.
- Are taking the following daily medications: immunosuppressants, antibiotics in the last three months.
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 for an individual their metabolic response to certain foods using the gut microbiome and their metabolic profile. Responses will include post-prandial appetite, levels of satiety, circulating glucose, insulin, ketone bodies and lipid levels. | Other | Dietary intervention |
Primary outcome
Gut microbiome profile
Time frame: 1-2 days
Assessment of participants' gut microbiome
Lipids
Time frame: 1 day to 2 weeks
Measurement of blood lipids
Glucose
Time frame: 2 weeks
Measurement of blood Glucose
Sleep
Time frame: 2 weeks
Record of sleep pattern using a wearable device (i.e. fitness watch)
Physical activity
Time frame: 2 weeks
Record of physical activity using a wearable device (i.e. fitness watch)
Hunger and appetite assessment
Time frame: 2 weeks
Record of hunger and appetite patterns using a digital app
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 37709944Bermingham KM, May A, Asnicar F, Capdevila J, Leeming ER, Franks PW, Valdes AM, Wolf J, Hadjigeorgiou G, Delahanty LM, Segata N, Spector TD, Berry SE. Snack quality and snack timing are associated with cardiometabolic blood markers: the ZOE PREDICT study. Eur J Nutr. 2024 Feb;63(1):121-133. doi: 10.1007/s00394-023-03241-6. Epub 2023 Sep 15.
- Derived from this study: PubMed 37528259Bermingham KM, Stensrud S, Asnicar F, Valdes AM, Franks PW, Wolf J, Hadjigeorgiou G, Davies R, Spector TD, Segata N, Berry SE, Hall WL. Exploring the relationship between social jetlag with gut microbial composition, diet and cardiometabolic health, in the ZOE PREDICT 1 cohort. Eur J Nutr. 2023 Dec;62(8):3135-3147. doi: 10.1007/s00394-023-03204-x. Epub 2023 Aug 2.
- Derived from this study: PubMed 36364763Louca P, Berry SE, Bermingham K, Franks PW, Wolf J, Spector TD, Valdes AM, Chowienczyk P, Menni C. Postprandial Responses to a Standardised Meal in Hypertension: The Mediatory Role of Visceral Fat Mass. Nutrients. 2022 Oct 26;14(21):4499. doi: 10.3390/nu14214499.
- Derived from this study: PubMed 35134821Merino J, Linenberg I, Bermingham KM, Ganesh S, Bakker E, Delahanty LM, Chan AT, Capdevila Pujol J, Wolf J, Al Khatib H, Franks PW, Spector TD, Ordovas JM, Berry SE, Valdes AM. Validity of continuous glucose monitoring for categorizing glycemic responses to diet: implications for use in personalized nutrition. Am J Clin Nutr. 2022 Jun 7;115(6):1569-1576. doi: 10.1093/ajcn/nqac026.
- Derived from this study: PubMed 34845532Tsereteli N, Vallat R, Fernandez-Tajes J, Delahanty LM, Ordovas JM, Drew DA, Valdes AM, Segata N, Chan AT, Wolf J, Berry SE, Walker MP, Spector TD, Franks PW. Impact of insufficient sleep on dysregulated blood glucose control under standardised meal conditions. Diabetologia. 2022 Feb;65(2):356-365. doi: 10.1007/s00125-021-05608-y. Epub 2021 Nov 30.
- Derived from this study: PubMed 34100082Mazidi M, Valdes AM, Ordovas JM, Hall WL, Pujol JC, Wolf J, Hadjigeorgiou G, Segata N, Sattar N, Koivula R, Spector TD, Franks PW, Berry SE. Meal-induced inflammation: postprandial insights from the Personalised REsponses to DIetary Composition Trial (PREDICT) study in 1000 participants. Am J Clin Nutr. 2021 Sep 1;114(3):1028-1038. doi: 10.1093/ajcn/nqab132.
- Derived from this study: PubMed 33722860Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.
- Derived from this study: PubMed 33568158Menni C, Louca P, Berry SE, Vijay A, Astbury S, Leeming ER, Gibson R, Asnicar F, Piccinno G, Wolf J, Davies R, Mangino M, Segata N, Spector TD, Valdes AM. High intake of vegetables is linked to lower white blood cell profile and the effect is mediated by the gut microbiome. BMC Med. 2021 Feb 11;19(1):37. doi: 10.1186/s12916-021-01913-w.
- Derived from this study: PubMed 32528151Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11.
- Individual participant dataSharing planned: No
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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 principal investigator
King's College London
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 Guy's and St Thomas' NHS Foundation Trust 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 3 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Berry, PhD (020 7848 4088, sarah.e.berry@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome profile (time frame: 1-2 days). 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?
On the ClinicalTrials.gov record for NCT03479866, which also lists 9 linked publications.
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 9 Feb 2021.