Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 1 Information Sheet for Research Participants for STUDY 2 Assessing metabolic profiling strategies for nutritional management of cardiovascular disease risk You will be given a copy of this Information Sheet and a signed copy of your consent form to keep, should you decide to participate in the study. You are being invited to take part in a research study investigating the effect of a dietary intervention on cardiovascular disease risk. This study has been reviewed an d approved by the London - Dulwich Research Ethics Committee and it is part of a grant funded by the National Health Research Institute (NIHR). It is organised by Imperial College London that will act as the main sponsor for this study and d elegated responsibi lities will be assigned to the NHS trusts taking part in this study. Before you decide if you would like to participate, 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 your friends, relatives and your GP if you wish. Part 1 tells you the purpose of the study and what will happen to you if you take part. Part 2 gives you more detailed information about the conduct of the study. As k us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. If you do decide to take part, please let us know beforehand if you have been involved in any other study during the last year. You are free to withdraw at any time without explanation. If you lose capacity to consent, you and your data will be immediately excluded from the study. Thank you for reading this Part 1 What is the purpose of this study? The aim of the present study is to evaluate the applicability of providing personalised dietary advice based on urine and blood composition advice to help people at risk of Cardio Vascular Disease (CVD) ) at their home environment to change their dietary h abits. The aim of the present study is to evaluate the applicability of providing personalised dietary advice based on urine and blood composition to help people at risk of Cardio Vascular Disease (CVD) at their home environment to change their dietary hab its. You will be asked to attend the NIHR/Wellcome Trust Imperial CRF at Hammersmith Hospital two weeks before the study. The aim of this visit will be to measure your weight, height, blood pressure, and you will be asked to provide 24 - h urine and faecal samples from the day before and blood and saliva samples upon arrival. You will be randomly assigned to the control or the target group . This will be done by a researcher non involved in the study that will have to open one of the two sealed envelopes that contained “target group” or “control group”. Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 2 If you are assigned to the target group, y ou will follow the Clinical Trial for 12 - weeks, in which a dietitian will provide personalised dietary advice based on knowledge of urine and blood compo sition from the samples collected at clinic every 2 - weeks in addition to 24 - h food diaries. If you are assigned to the control group, you will mirror the intervention group but will receive standard dietary recommendations according to dietary guidelines f or the management of CVD - Risk . The changes in CVD - risk factors will be compared between the intervention and the control group. Furthermore, the 24 - h food diaries of the intervention and the control groups will be assessed against objective measurements of their dietary habits using the mathematical models built during the in - patient study 1 Who is suitable to participate? • Male and female of all ethnicities, at risk of CVD aged between 30 and 65 years. • Participants compliant with at least three of the next criteria: o Body mass index (BMI) of 20 - 35 o r ≥25 and <35kg/m2, ▪ BMI is equal to body weight (kg) divided by height squared (m 2 ) o Systolic Bloop Pressure (BP) BP≥140 or diastolic BP≥90 mmHg or under antihypertensive medication, o LDL - cholesterol ≥ 4.14 mmol/l and HDL - cholesterol ≤1.03 mmol/l (men) or ≤1.29 mmol/l (w omen), o Family history of premature C oronary Heart Disease and waist circumference >102cm in men or > 88cm in women You are NOT suitable to participate if you have any of the below : • Gained or lost ≥ 3kg weight in the past three months • Taken prescription medicines having an impact on metabolism, appetite r egulation and hormonal regulation • Taken any dietary supplements in the last 6 months • Any chronic illness or being diagnosed with HIV • Any gastrointestinal disorder e.g. Crohn’s disease, coeliac disease or irritable bowel syndrome • A history of drug or alcoho l abuse in the last 2 years • Pregnancy (all women of child bearing age will undergo a pregnancy test). • H ave been involved in any other study during the 12 weeks Do I have to take part? It is entirely up to you whether or not to take part. If you do we will ask you to sign a consent form. You are free to withdraw at any time and you do not have to give a reason. A decision either not to take part or to withdraw from the study will not affect the standard of care you receive. Will I get paid for particip ating? You will be reimbursed for any inconvenience caused due to the study. You will receive £ 8 0 for completing the entire study that will be paid at the end of the study You will receive £10 for each of the 8 study visits. Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 3 What will I have to do? If you do decide to participate, you will first be asked to attend the Clinical Investigations Unit at Hammersmith Hospital where you will be interviewed and examined by one of the research doctors and asked to complete a medical and lifestyle questionnair e (Screening Questionnaire and screening form) . You will have a blood test (to check your liver, kidneys, cholesterol and ensure that you are not anaemic or diabetic) and height, weight, waist circumference measurements will also be taken. You will also ha ve an electrocardiogram (ECG). This is a non - invasive test to look at the health of your heart. Your blood pressure will also be recorded. Moreover, the resting energy expenditure will be assessed to enable the planning of a eucaloric diet by open loop ind irect calorimeter which is a non - invasive test. All women of child bearing age will be asked to have a pregnancy test. If you do decide to participate, you will be randomly assigned to the control group or the target group. This means that you will not be able to choose the group. This will be done by a researcher non involved in the study that will have to open one of the two sealed envelopes that contained “target group” or “control group”. You will be asked to attend the NIHR/Wellcome Trust Imperial CR F at Hammersmith Hospital for a few hours every two weeks during a 12 - week period and you would be expected to stay in the research facility until the end of your allotted time If you are assigned to the control group will receive standard advice according to dietary guidelines for the management of CVD - Risk and based on your dietary intake recorded by food diaries you’re your are assigned to the target group , you will mirror the control group but will receive personalised dietary advice based on ch anges in your urine and blood composition in response to the diet. You will be asked to provide feces samples , fasting urine and blood samples at the beginning and at the end of the 12 week period. Moreover, the C - reactive protein (CRP , indicator of inflam mation in your body and it is used to evaluate your risk of developing coronary artery disease, a condition in which the arteries of your heart are narrowed ) and the HbA1c (indicator of your average blood sugar level f or the past two to three months) will be also measured at the beginning and at the end of the study. Furthermore, you will have to attend the Clinical Unit 3 - h after lunch, once every two weeks, for 12 weeks. Blood pressure, weight, height and waist circumference will be measured at each vis it. You will ask to provide from the day before 24 - h urine, f eces samples and corresponding 24 - h food diaries. Finally, you will be asked to provide spot u rine, and blood samples at each visit upon arrival at the unit. Please, be aware that DNA from samples will be analysed but the results will not be fed back to the participants What are the possible disadvantages and risks of taking part? In the event that we discover something about your health that you were unaware of, for example if your kidney tests are abnormal or if you have diabetes, we would immediately inform you of this and inform your GP so that you can be referred to an appropriate spe cialist. If you require more urgent assessment we wou ld arrange this for you immediately within the hospital. Some of the procedures in this study, such as the recording of your weight, height and blood pressure present no risk to you. Other procedures, s uch as taking blood samples, can cause Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 4 mild discomfort. The risks of taking a blood sample include: slight discomfort when the needle is inserted and possible bruising and a localised infection. E lectrocardiogram (ECG) are safe, non - invasive, painless tes ts and have no major risks. However, you may develop a mild rash or skin irritation where the electrodes were attached. If any paste or gel was used to attach the electrodes, you may have an allergic reaction to it. This irritation usually goes away once t he patches are removed, without requiring treatment. These procedures will only be carried out by experienced doctors and they are also part of the research team or direct care team under aseptic conditions to minimise all these risks. What happens when the research study stops? Once the study has finished, the results of the study can be made available to you. If you have any problems immediately following the study, then you should contact one of the research doctors on the numbers provided in Part 2. What if there is a probl em Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2. Will my taking part in the study be kept confidential? Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. The details are included in Part 2. This completes part 1. If the information in Part 1 has interested you and you are considering participation, please r ead the additional information in Part 2 before making any decision. Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 5 Part 2 What if new information becomes available? Sometimes during the course of a research study, new information becomes available about the treatment that is being studied. If this happens, your research doctor will tell you about it and discuss with you whether you want to continue in the study. If you decide to continue in the study you will be asked to sign an updated consent form. Also, on receiving new information your res earch doctor might consider it to be in your best interests to withdraw you from the study. What will happen if I don’t want to carry on with the study? You can withdraw from the study at any time and you do not need to give a reason. Any stored blood or urine samples that can still be identified as yours will be destroyed. If you leave the study before the end, you will be partially reimbursed What if something goes wrong? Imperial College London holds insurance policies which apply to this st udy. If you experience serious and enduring harm or injury as a result of taking part in this study, you may be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compe nsation. If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator ( Professor Gary Frost, through his secretary on 020 8383 3242 or by email at g.frost @imperial.ac.uk ). The normal National Health Service complaint complaints mechanisms are also available to you. If you are still not satisf ied with the response, you may contact the Imperial AHSC Joint Research Compliance Office. Wh at can I do if I have any complaints or concerns? If you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Principal Investigator, Professor Gary Frost, through his secretary on 020 8383 3242 or by email at g.frost @imperial.ac.uk Moreover, you could contact the Patient advice and liaison service (PALS) to raise concerns ( IMPERIAL.PALS@NHS.NET ). PALS is an independent service available to patients, relatives, carers or visitors. Will my taking part in this study be kept confidential? All information that is collected about you during the course of the research will be kept strictly confidential. Any information about you that leaves the hospital will have your name and address removed so that you cannot be recognised fro m it. Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 6 All electronic data about you will be stored on Imperial College departmental database. This is a confidential computer system which requires a specific password for access and can only be viewed by authorised persons. It is a requirement that your GP is informed of your participation in this study. All staff involved in the study is aware of the requirements of the Data Protection Act and adherence to Good Clinical Practice (GCP). You will be give n a personal study code number which will be used thr oughout the study and in the analysis of data. The study codes will be kept on our departmental database. All personal data (PID data) will be stored as GCPR Requirements for 10 years after the study has finished. Specifically, PID data will be stored in locked filing cabinets in the Section of Investigative Medicine, Imperial College London. Only members of the Section of Investigative Medicine will have access to this. Personal data will only be stored on computers that can only be accessed from within t he Section of Investigative Medicine, Imperial College London. The data will be analysed in the Section of Investigative Medicine and in the section of computational and systems medicine. No personal data will be present on any of the data. Individual ano nymous study codes will be used for each volunteer on any samples/documents. All documents will be password protected. Personal data, including identifiable data (e.g. consent forms) , must be stored for 10 years following completion of the study according to the Imperial College London retention schedule Research data will be stored for 10 years as per other studies performed within the Section of Investigative Medicine on completion of the study as college policy. It will be archived as per Imperial Coll ege Standard operating procedures. What will happen to the results of the research study? The results are likely to be published six months following the study. Your confidentiality will be ensured at all times and you will not be identified in any publication. At the end of the study, the results of the study can be made available to you. Contact for Further Information The researchers and doctors involved in the study, Professor Gary Fr ost , Dr Isabel Garcia - Perez and Dr. Ed Chambers, will be avai lable by telephone During working hours through Professor Ga ry Frost’s secretary 020 8383 3242 At all other times through Hammersmith Hospital switchboard 020 8383 1000 Transparency wording for study participants Imperial College London is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 7 identifiable information about you for ten years after the study has finished in relation to data subject consent forms and for ten years after the stu dy has completed in relation to primary research data. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from th e study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally - identifiable information possible. You can find out more about how we use your information from the Principal Invest igator: Prof Gary Frost, Head of the Nutrition Research Section, 6th Floor Commonwealth Building, Hammersmith Hospital, Imperial College London, Du Cane Road, London, W12 0NN Tel: 020 8383 2820 LEGAL BASIS As a university we use personally - identifiable information to conduct research to improve health, care and services. As a publicly - funded organisation, we have to ensure that it is in the public interest when we use personally - identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research. CONTACT US If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your information, please contact Imperial College London’s Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on 020 7594 3502 and via post at Imperial College London, Data Protection Office r, Faculty Building Level 4, London SW7 2AZ. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator. Imperial College London and Imperial College Healthcare NHS Trust will collect information from you and/or your medical records for this research study in acco rdance with our instructions. Version 3 – 21 st Febru ary 2019 IRAS ID: 237962/ REC Ref:18/LO/2042 8 Imperial College London and the Imperial College Healthcare NHS Trust will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is reco rded for your care, and to oversee the quality of the study. Individuals from Imperial College London and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The only people in Imperial Colleg e London and the Imperial College Healthcare NHS Trust who will have access to information that identifies you will be people who need to contact you for follow - up or to audit the data collection process . The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details. Imperial College London and the Imperial College Healthcare NHS Trust will keep identifiable information about you from this study for 10 years after the study has finished. When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities , NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research P articipants GPs will be informed of their involvement in the study.