FEED Participant information sheet

You are being invited to take part in a research project. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.

why is this research being conducted?

The aim of this study is to describe contemporary plant-based diets (e.g. flexitarian, vegetarian, and vegan) and diets containing meat and fish in UK adults and to examine the motivations and characteristics of the adults consuming these diets.

We would like to assess the stability of markers of dietary intakes across different methods of dietary assessment, and differences in nutritional status in adults following different diets through comparing circulating concentrations of haemoglobin, lipids [low density lipoprotein (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, total cholesterol, triglycerides], and vitamins B12, and D.

The Principal Researcher is Keren Papier, who is employed with the Nuffield Department of Population Health at the University of Oxford. This project is being conducted in collaboration with the Wellcome “Our Planet Our Health” programme “Livestock, Environment and People (LEAP)” and the World Health Organization.

Why have I been invited?

You have been invited to participate because you are aged 18 years or older, living in the UK, have completed the FEED survey and provided consent to be contacted for future research.

Do I have to take part?

No. Please note that participation is voluntary. We have also included a ‘Prefer not to say’ option for each set of questions in the online survey. If you do decide to take part you may withdraw at any point for any reason, by contacting the research team (details below) and asking to withdraw your submission based on the email address you submitted. Once you have withdrawn from the study, we will not contact you further and your data will no longer contribute to further research but we will not be able to remove any data used in research that has already been published or submitted for publication. You may also ask any questions before deciding to take part by contacting the research team.

You may take part in the online dietary assessment part of the study only, the blood collection only, or both. You can specify which part of the study you wish to take part in on the online consent form. Please note that the opportunity to participate in the blood collection will be given on a first-come-first served basis until the participant quota in each diet group is met, and priority may be given to participants who also completed the dietary assessment.

What is involved?

If you give your consent to take part, you will be invited via email to provide additional data to help assess the stability of markers of dietary intakes across different methods of dietary assessment:

1. You will be asked to complete the diet portion of the FEED survey again (20 minutes), followed by a 24-hour dietary recall on the same day.
2. You will be asked to complete a second 24-hour dietary recall 2 weeks later via an email reminder. Each recall should take under 20 minutes.
3. You will be asked to provide capillary blood samples to assess your haemoglobin, lipids, vitamin B12, and vitamin D levels. You will receive a home blood testing kit (after providing your postal address on the electronic consent form), which will include a letter with detailed instructions on how to collect the blood sample, all of the necessary equipment and the prepaid return packaging. Two test tubes are required to measure all of the biomarkers using ~20 drops (850 microliters) of blood in total.

what are the possible disadvantages and risks in taking part?

We do not foresee any risks for taking part in the dietary survey, and you may close the online platform at any time if you do not wish to continue. If you are taking part in the blood collection, clear instructions will be provided with your home testing kit to minimise any risks. There is a small possibility of bruising and/or infection at the test site. It’s highly unlikely, but there is a small risk of complications — including scarring, a haematoma (collection of blood), loss of sensation in finger (nerve damage), and premature death of skin cells (necrosis). If your wound site becomes red, hot, or swollen, we advise you to seek medical advice. Risk of increased bleeding is higher if you take anticoagulation medication, however, since it's a fingerprick test, the risk of serious complications is very low.

are there any benefits in taking part?

If you compete the full online dietary assessment, you will receive a personalised nutrient report based on your 24-hour recall responses. If you take part in blood collection, you will also receive the results of your blood test (haemoglobin, lipids, vitamin B12, and vitamin D) in a password-protected document via email attachment. You will be notified via email as soon as possible in the event of any out-of-range blood test results, and advised to discuss the result with your GP surgery.

Please note that in the event of a void result, unfortunately we are not able to provide blood test results. A "void" blood test result means that the test was not able to provide useful information. This can happen for several reasons, such as:

• Insufficient sample: There wasn’t enough blood to perform the test properly.
• Sample issues: The blood sample might have clotted, been contaminated, or was improperly stored, which makes the results unreliable.
• Technical error: Sometimes, there’s a machine or lab processing error.

what information will be collected and why is the collection of this information relevant for achieving the research objectives?

Personal data we will collect in order to post kits and perform blood tests will include your name, email, sex, date of birth and postal address.

Your personal data will only be kept for the duration of this project (five years) unless you provide your consent (optional) to be contacted again in future, in which case contact details (and your consent form) will be retained for 10 years. All research data and records (including consent forms) will be stored securely on the Nuffield Department of Population Health, University of Oxford servers for 10 years and then deleted. Blood samples will be disposed of within 24 hours after analysis. The results, presented as averages for groups, not as individual data, will be published in scientific journals, presented at research meetings, and made available on the FEED study webpage. Anonymised data may be shared through secure mechanisms with other approved researchers in the interest of open and transparent science. The identifiable information that you provide us with will be stored on a secure server within the Nuffield Department of Population Health and will only be accessed by individuals within the research team for the purpose of this research.

Who will have access to my data?

The University of Oxford is the data controller with respect to your personal data and, as such, will determine how your personal data are used in the study. The University will process your personal data for the purpose of the research outlined above. Research is a task that we perform in the public interest. Further information about your rights with respect to your personal data is available from the University’s Information Compliance team.

For those taking part in the additional data collection (blood samples), the data processor (Thriva Ltd) will have access to participant name and addresses for the purpose of mailing blood test kits via their preferred subcontractor (Royal Mail). Thriva will have access to personal data required to process the blood samples, and to report any out-of-range results. Thriva guarantee that all customer data will be handled in line with all applicable laws and regulations, and that any data held shall be deleted upon written request by the University or termination of the study.

The data you provide will be used by the research team. Responsible members of the University of Oxford may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.

We would also like your permission to share anonymised data with students and other researchers (e.g. in online databases). All of your identifying information will be removed from the data before it is shared with students or other researchers or results are made public.

Who has reviewed this study?

This project has been reviewed by, and received ethics clearance through, a subcommittee of the University of Oxford Central University Research Ethics Committee [R79226/RE001].

Who do I contact if I have a concern or I wish to complain?

If you have a concern about any aspect of this study, please contact the research team (Feedstudy@ndph.ox.ac.uk), and we will do our best to answer your query. We will acknowledge your concern within 10 working days and give you an indication of how it will be dealt with. If you remain unhappy or wish to make a formal complaint, please contact the University of Oxford Research Governance, Ethics & Assurance (RGEA) team at rgea.complaints@admin.ox.ac.uk or on 01865 616480.

further information and contact details

If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact:

Dr Keren Papier
Cancer Epidemiology Unit
Richard Doll Building
Oxford OX3 7LF
Email: Feedstudy@ndph.ox.ac.uk

FEED Study information sheet Version 2.2 September 2024