Status:
UNKNOWN
Personalised Responses to Dietary Composition Trial
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Massachusetts General Hospital
Conditions:
Diabetes
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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, an...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 4 2023
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT03479866
Start Date
June 4 2018
End Date
May 4 2023
Last Update
February 9 2021
Active Locations (1)
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1
King's College London
London, England, United Kingdom, SE1 7EH