A dual-site dietary intervention study to integrate dietary assessment methods

Plain English summary of protocol

Background and study aims
Diet has a huge impact on the health and well-being of individuals and is a major contributor to the development of a range of chronic health conditions, such as diabetes, cardiovascular diseases, and many cancers. Many countries are facing rising levels of obesity and diet-related disease due to changes in dietary choices and eating behaviour, as well as more sedentary lifestyles. The robustness and impact of strategies aimed at addressing nutrition-related problems are consistently undermined by misreporting of dietary intake caused by our lack of an accurate tool to assess and monitor dietary intakes. Self-reporting tools used traditionally to capture information about diet include Food Frequency Questionnaires (FFQs), 24-hour dietary recalls and food diaries. These tools struggle to categorise and represent accurately dietary intake and often involve costly expert researcher support, a substantial burden to study/survey participants and are subject to poor compliance, dietary change, and significant reporting bias. To improve dietary reporting, the researchers will bring together three additional technologies which have shown promise in improving accurate reporting of dietary intake. These are urine biomarkers, capillary blood biomarkers and wearable micro cameras. The overall aim of this study is to improve the accuracy of dietary reporting by combining all these tools.

Who can participate?
Healthy volunteers aged 18 to 70 and have a Body Mass Index (BMI) between 20-30 kg/m2

What does the study involve?
Participants will attend to undergo two 4-day dietary interventions and return the samples on the 5th day with a minimum of 1 week between both visits, with the administration of a healthy diet intervention compliant with current dietary healthy guidelines and an unhealthy diet intervention. Diets will consist of a 2-day repeating menu delivered twice over the 4 days.
Participants will be given a micro camera to wear for the duration of the two, four-day study periods. The camera will automatically capture images of everything that a participant eats and drinks at regular intervals (e.g., one image per second) and must be worn continuously during the study period, including when at home. Participants will also collect first morning urine and evening urine samples on all study days plus a first morning urine on day 5. These samples will be returned to the research facility each day the participant attends. In addition to the urine samples, participants will also collect a capillary blood sample. These blood samples will be collected by the participant on days 1, 2 and 4 of each study period. The blood collection uses a device called ‘OneDraw’ and involves attaching the devices to your upper arm where it then collects 3 small drops of blood. Participants will collect these samples while at the research centre, and a researcher will be present if the participant requires any assistance with the sample collection.
Participants will also use two online self-reporting dietary assessment tools called eNutri and Intake24. These online tools are simple to use and can be used on any type of device (laptop, tablet, smartphone) which has a web browser. Intake24 records a person’s diet from the previous 24 hours, so participants will complete this a total of eight times during the study (four times for each study period). eNutri features a graphical FFQ that asks participants about their dietary intake over a longer period. Participants will record their dietary intake using eNutri at the start of the study to capture their habitual diet and again at the end of each study period to capture foods/drinks consumed in the test diets.
Participants will be asked to complete a short questionnaire on how easy/difficult they found completing the five different dietary assessment methods

What are the possible benefits and risks of participating?
Participants will receive £400 upon completion of the study to reimburse them for the time they have taken to attend study visits.

Where is the study run from?
1. Imperial College London (UK)
2. Hugh Sinclair Unit for Human Nutrition at the University of Reading (UK)

When is the study starting and how long is it expected to run for?
September 2022 to October 2024

Who is funding the study?
1. Medical Research Council (MRC) (UK)
2. Biotechnology and Biological Sciences Research Council (BBSRC) (UK)

Who is the main contact?
1. Dr Katerina Petropoulou, katerina.petropoulou12@imperial.ac.uk
2. Dr Michelle Weech, m.weech@reading.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

Imperial College London
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
Email	r.ezra@imperial.ac.uk
Website	https://www.ic.ac.uk/clinicalresearchgovernanceoffice
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Research council

Results and Publications

Study outputs

Additional files

44059_PIS_v2.0_07June2023.pdf

Editorial Notes

04/10/2023: Internal review.
17/08/2023: Trial's existence confirmed by the Health Research Authority (HRA) (UK).