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Personalised Responses to Dietary Composition Trial (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479866
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : December 23, 2019
Sponsor:
Collaborators:
King's College London
Massachusetts General Hospital
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: N/A
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, 2022
Estimated Study Completion Date : May 4, 2022

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Gut microbiome profile [ Time Frame: 1-2 days ]
    Assessment of participants' gut microbiome

  2. Lipids [ Time Frame: 1 day to 2 weeks ]
    Measurement of blood lipids

  3. Glucose [ Time Frame: 2 weeks ]
    Measurement of blood Glucose

  4. Sleep [ Time Frame: 2 weeks ]
    Record of sleep pattern using a wearable device (i.e. fitness watch)

  5. Physical activity [ Time Frame: 2 weeks ]
    Record of physical activity using a wearable device (i.e. fitness watch)

  6. Hunger and appetite assessment [ Time Frame: 2 weeks ]
    Record of hunger and appetite patterns using a digital app


Other Outcome Measures:
  1. Inflammation [ Time Frame: 1 day ]
    IL-6

  2. Glucose metabolism [ Time Frame: 2 weeks ]
    C-peptide

  3. Metabolomics [ Time Frame: 1 day ]
    NMR analysis of a panel of 220 metabolites

  4. Systolic and Diastolic Blood pressure [ Time Frame: 6 hours ]
    Clinic Systolic and Diastolic Blood Pressure

  5. Body composition [ Time Frame: 1 day ]
    Visceral fat in kg

  6. Digestive enzymes [ Time Frame: 1 day ]
    Salivary amylase concentration

  7. Pulse wave velocity [ Time Frame: 1 day ]
    (subgroup n=50) measure of pulse wave velocity using carotid and femoral artery

  8. Carotid intima-media thickness [ Time Frame: 1 day ]
    (subgroup n=50) Measure of carotid intima-media thickness using ultrasound

  9. Fat quantification [ Time Frame: 1 day ]
    (subgroup n=50) Quantification of liver, visceral and subcutaneous adipose tissue from XMR

  10. Carotid plaque [ Time Frame: 1 day ]
    (subgroup n=50) Grading of carotid plaque using ultrasound



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sarah Berry, PhD 020 7848 4088 sarah.e.berry@kcl.ac.uk

Locations
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United States, Massachusetts
Translational and Clinical Research Center, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: David A Drew, PhD    617-724-7360    DADREW@mgh.harvard.edu   
Principal Investigator: Andrew T Chen, MPh         
United Kingdom
King's College London Recruiting
London, England, United Kingdom, SE1 7EH
Contact: Sarah Berry    020 7848 4088    sarah.e.berry@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Massachusetts General Hospital
Investigators
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Principal Investigator: Tim Spector King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03479866    
Other Study ID Numbers: 236407
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Gut microbiome
Personalised Nutrition
Metabolic health
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Heart Diseases
Cardiovascular Diseases