Pilot clinical trial on using health and dietary monitoring technologies to prevent diet-related diseases
| ISRCTN | ISRCTN11564218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11564218 |
| IRAS number | 330755 |
| Secondary identifying numbers | IRAS 330755, CPMS 59206 |
- Submission date
- 18/10/2023
- Registration date
- 24/10/2023
- Last edited
- 03/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Unhealthy diets are associated with metabolic changes and increased risk of non-communicable diseases (NCDs). However, current understanding of the relationship between diet and the development of NCD is limited by a number of factors. These include a lack of understanding of dietary mechanisms that drive NCD, inaccurate tools to collect dietary information, a nascent understanding of the role of personalised nutrition, and the lack of data in vulnerable groups where NCDs are often over-represented.
The relationship between dietary intake and the development of NCD is complex. The understanding of how diet relates to the development of metabolic risk factors on a background of non-modifiable risk factors is improving with the greater understanding of the metabolic pathways that are responsive to dietary profile and lead to change in NCD risk. Tools that profile the genome, metabolome, epigenome, microbiome, and inflammation are key to understanding the impact of diet on NCDs. However, these systems are mostly studied in isolation and their relative importance of how they interact with each other is not understood.
Who can participate?
Healthy volunteers (male and female), aged 18-65 years old, with BMI over 25 kg/m² and two other risk factors.
What does the study involve?
Participants will need to wear a micro-camera that tracks their dietary intake and a wristband that measures their physical activity and sleeping patterns for seven days each on three separate occasions. In addition, while the volunteers are wearing the camera and the wristband, they will need to complete a five-day food diary online. At the end of the first and third period of wearing the devices and completing the food diaries, the volunteers will be asked to attend two studies, where they will have their body composition and general health assessed, provide blood, stool, breath, and urine samples. In addition, during these two study visits and only at the Imperial College London site, the volunteers will be asked to undergo a mixed meal tolerance test where the participants will consume a standard meal and then have blood samples taken over a six hours period.
At the end of the second period of wearing the devices and completing the food diaries, the volunteers will be asked to attend a 30-minutes study visit where they will only have their body composition and general health assessed (no biofluids will be taken). After the volunteers have completed all study visits, they will be asked to complete short questionnaires through which they will be able to express their views on participating in the study.
What are the possible benefits and risks of participating?
Participants will receive £200 upon completion of the study to reimburse them for the time they have taken to attend study visits.
No risks
Where is the study run from?
1. Imperial College London (UK)
2. Aristotle University Thessaloniki (Greece)
3. CIC bioGUNE (Center for Cooperative Research in Biosciences) (Spain)
4. University of Valencia (Spain)
5. Atlanta Clinical Trials (Ireland)
When is the study starting and how long is it expected to run for?
January 2023 to September 2024
Who is funding the study?
1. European Union under Horizon Europe project
2. UK Research and Innovation
Who is the main contact?
1. Dr Aygul Dagbasi, a.dagbasi16@imperial.ac.uk
2. Monica Hill, m.mischie18@imperial.ac.uk
Contact information
Principal Investigator
Nutrition Research Section
Hammersmith Hospital Campus
Imperial College
6th Floor
Commonwealth Building
Du Cane Road
London
W12 0NN
United Kingdom
 ORCID ID |
0000-0003-0529-6325 |
|---|---|
| Phone | +44 (0)20 7594 0959 |
| g.frost@imperial.ac.uk |
Public, Scientific
Nutrition Research Section
Imperial College London
Hammersmith campus
7th floor Commonwealth Building
DuCane Road
London
W12 0NN
United Kingdom
| ORCID ID |
0000-0002-3230-3562 |
|---|---|
| Phone | +44 7708369942 |
| a.dagbasi16@imperial.ac.uk |
Public, Scientific
Nutrition Research Section
Imperial College London
Hammersmith campus
7th floor Commonwealth Building
DuCane Road
London
W12 0NN
United Kingdom
| Phone | +44 7340626852 |
|---|---|
| m.mischie18@imperial.ac.uk |
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Prevention |
| Participant information sheet | 44435 PIS_CoDiet v1.2 10Oct2023.pdf |
| Scientific title | Combatting Diet Related Non-Communicable Diseases through Enhanced Surveillance |
| Study acronym | CoDiet |
| Study hypothesis | Integrating multiple methods of assessing dietary intake (micro-camera technology and online food diaries) with collection and analysis of a wide range of bio fluids (blood, urine, faeces and breath) and with non-invasive body composition measurements can help understand better the relationship between dietary intake and risk of non-communicable diseases. |
| Ethics approval(s) |
1. Approved 03/11/2023, London - Surrey Research Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8088; surrey.rec@hra.nhs.uk), ref: 23/PR/1109 2. Approved 24/10/2023, Cork Research Ethics Committee (Lancaster Hall, 6 Little Hanover Street, Cork, T12 WV09, Ireland; +353(0)21204901901; crec@ucc.ie), ref: ECM 3 (III) 24/10/2023 3. Approved 18/10/2023, Ethics Committee on Human Research at the University of Valencia (Avda. Blasco Ibañez, 13, Valencia, 46010, Spain; +34 (0) 963864109; vicerec.investigacio@uv.es), ref: 2023-MED-2857718 4. Approved 19/01/2023, Committee for Ethics in Research, Aristotle University Thessaloniki (Aristotle University, Thessaloniki, 54124, Greece; +3023109988427; ethics@rc.auth.gr), ref: 20023/2023 5. Approved 29/09/2023, Ethics Committee for Research with Medicinal Products in the Basque Country (Department of Health of the Basque Government C/ Donostia-San Sebastián, nº 1, Vitoria-Gasteiz, 01010, Spain; +34 945 01 92 96; ceic.eeaa@euskadi.eus), ref: PI2023134 |
| Condition | Healthy individuals at risk of developing non-communicable diseases (heart disease, type 2 diabetes, cancer). |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 19/01/2023 |
| Overall study end date | 30/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 01/12/2023 |
| Recruitment end date | 01/03/2024 |
Locations
Countries of recruitment
- England
- Greece
- Ireland
- Spain
- United Kingdom
Study participating centres
Du Cane Rd
Shepherd's Bush
London
W12 0HS
United Kingdom
First Floor
Blackpool
Cork
T23 R50R
Ireland
Valencia
46010
Spain
Thessaloniki
54124
Greece
Derio, Bizkaia
48160
Spain
Sponsor information
University/education
Research Governance and Integrity Team
Academic Health Science Centre
Imperial College London and Imperial College Healthcare NHS Trust
Room 221
Medical School Building
St Mary’s Hospital
Praed Street
London
W2 1NY
England
United Kingdom
| Phone | +44 (0)20 7594 8081 |
|---|---|
| r.ezra@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in high-impact peer reviewed journals. Work in progress will also be presented at CoDiet group meetings and at relevant conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made publicly available. All data will be published as group summaries. Anonymised data will be shared with the partners of this project so that they can perform the lab analyses on the samples and also for them to conduct the data analysis. Consent will be taken from all participants prior to joining the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 10/10/2023 | 20/10/2023 | No | Yes |
Additional files
Editorial Notes
03/04/2024: The overall end date was changed from 01/04/2024 to 30/09/2024.
12/12/2023: Internal review.
06/11/2023: The following changes were made:
1. The ethics approval was added.
2. The recruitment start date was changed from 15/10/2023 to 01/12/2023.
02/11/2023: Internal review.
01/11/2023: The ethics approval date was added from the Ethics Committee on Human Research at the University of Valencia and the reference number was changed from 2953480 to 2023-MED-2857718.
20/10/2023: Trial's existence confirmed by UKRI
