Healthy individuals at risk of developing non-communicable diseases (heart disease, type 2 diabetes, cancer). Other
Conditions
Interventions
Participants will be asked to wear a micro-camera attached to glasses for 3 one week periods that will record what they eat. In addition, they will need to wear a physical activity monitor
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and Female aged 18-65 years old 2. Individuals at high risk of developing a non-communicable disease assessed through the metabolic risk score: 2.1. Overweight or obesity (BMI greater than 25 kg/m²) plus any two of the four factors: 2.2. Raised triglycerides: = 100 mg/dL (1.7 mmol/L) 2.3. Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males or < 50 mg/dL (1.29mmol/L) in females. 2.4. Raised blood pressure: systolic BP = 130 or diastolic BP = 85 mm Hg. 2.5. Raised fasting plasma glucose (FPG): = 90 mg/dL (5.0 mmol/L). 3. Current smokers
Exclusion criteria
Exclusion criteria: 1. Suffer from the following conditions: type 2 diabetes, chronic gastrointestinal conditions (Crohn’s disease, irritable bowel syndrome, ulcerative colitis etc.), acute infectious diseases, cardiovascular diseases, hypertension, autoimmune conditions, 2. Were on antibiotic treatment in the 12 weeks preceding enrolment of the clinical trial, 3. Pregnant or currently breastfeeding, 4. Are currently participating in other clinical trials or participated in another trial within the last 12 weeks, 5. Require any medical interventions during the study period, 6. Cannot give consent by yourself.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The effectiveness of the micro-camera technology to measure and determine the volunteers’ food and drinks intake continuously for a week during weeks 1, 4 and 8 in comparison to the dietary information that the volunteers input in the online food diaries during weeks 1, 4 and 8. 2. Determination of the volunteers’ non-communicable disease risk during their participation in the study at the end of weeks 1 and 8 by measuring: 1) the metabolites found in the volunteers’ stool, fasted urine, fasted blood, and breath samples using nuclear magnetic resonance, liquid chromatography, and gas chromatography, 2) the volunteers’ dietary habits using the camera technology and online food diaries and 3) the volunteers’ physical activity using wristband activity monitors. Information from 1), 2) and 3) will be combined using machine learning to obtain a comprehensive non-communicable disease risk for each volunteer at the end of weeks 1 and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Body composition measurements, cardiovascular system health and autonomic nervous system measurements conducted at the end of weeks 1, 4 and 8: 1.1. Body composition will be measured using a Body Composition Analyser, called InBody 1.2. Cardiovascular system and autonomic nervous system health will be measured using a heart rate variability and accelerated photoplethysmograph analyzer, called SA3000P 1.3. Cardiovascular system health will also be measured using an Advanced Glycation End (AGE) products analyser 2. Physical activity levels and sleeping patterns of the volunteers measured continuously for a week during weeks 1, 4 and 8 using wristband activity monitors. 3. Assess the volunteers’ acceptance of the developed technologies (micro-camera, online food diaries, physical activity and sleep monitor, samples donation and non-invasive body measurements) at the end of the clinical trial using questionnaires and interviews. | — |
Countries
England, Greece, Ireland, Spain, United Kingdom
Contacts
Public ContactAygul;Monica Dagbasi;Hill
;
Outcome results
None listed