Personalised Responses to Dietary Composition Trial (PREDICT)
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|ClinicalTrials.gov Identifier: NCT03479866|
Recruitment Status : Unknown
Verified February 2021 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : March 27, 2018
Last Update Posted : February 9, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Heart Diseases Diet Habit Diet Modification Microbial Colonization Healthy Obesity Metabolism||Other: Dietary intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Predicting Inter-individual Differences in Biochemical and Behavioral Response to Meals With Different Nutritional Compositions Using Metabolomic and Microbiome Profiling.|
|Actual Study Start Date :||June 4, 2018|
|Estimated Primary Completion Date :||May 4, 2023|
|Estimated Study Completion Date :||May 4, 2023|
Experimental: Dietary intervention
2 week dietary intervention using standardized test meals
Other: Dietary intervention
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.
- 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
- Inflammation [ Time Frame: 1 day ]IL-6
- Glucose metabolism [ Time Frame: 2 weeks ]C-peptide
- Metabolomics [ Time Frame: 1 day ]NMR analysis of a panel of 220 metabolites
- Systolic and Diastolic Blood pressure [ Time Frame: 6 hours ]Clinic Systolic and Diastolic Blood Pressure
- Body composition [ Time Frame: 1 day ]Visceral fat in kg
- Digestive enzymes [ Time Frame: 1 day ]Salivary amylase concentration
- Pulse wave velocity [ Time Frame: 1 day ](subgroup n=50) measure of pulse wave velocity using carotid and femoral artery
- Carotid intima-media thickness [ Time Frame: 1 day ](subgroup n=50) Measure of carotid intima-media thickness using ultrasound
- Fat quantification [ Time Frame: 1 day ](subgroup n=50) Quantification of liver, visceral and subcutaneous adipose tissue from XMR
- Carotid plaque [ Time Frame: 1 day ](subgroup n=50) Grading of carotid plaque using ultrasound
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479866
|Contact: Sarah Berry, PhD||020 7848 firstname.lastname@example.org|
|King's College London||Recruiting|
|London, England, United Kingdom, SE1 7EH|
|Contact: Sarah Berry 020 7848 4088 email@example.com|
|Principal Investigator:||Tim Spector||King's College London|
|Responsible Party:||Guy's and St Thomas' NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||March 27, 2018 Key Record Dates|
|Last Update Posted:||February 9, 2021|
|Last Verified:||February 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|