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OptiBiotix Appetite StudyParticipant Information SheetInvitationYou are being invited to take part in a research study. 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.What is the purpose of the study?The purpose of this study is to investigate the effects of a drink on appetite, cravings and food intake in overweight and obese women following healthy eating advice. The drink contains a combination of fibre, prebiotics and chromium to support healthy weight management. Participants will be given either the test drink or a placebo to consume three times a day, i.e. before each main meal, for four weeks. This study is being conducted by the Oxford Brookes Centre for Nutrition and Health (OxBCNH) on behalf of OptiBiotix Health Plc, the developers of the product. The Oxford Brookes Centre for Nutrition and Health is a centre for nutrition research. We share our expertise with the food and nutrition industry worldwide by providing research and consultancy services to them. Why have I been invited to participate?You have expressed an interest in taking part in this study and this information has been provided to help you understand what is involved if you do decide to participate. Do I have to take part?It is up to you to decide whether or not to take part. If you do decide to take part, you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part, you are still free to withdraw at any time and without giving a reason.For students of Oxford Brookes University, choosing to either take part or not take part in the study will have no impact on your marks, assessment or future studies.What are the inclusion and exclusion criteria?You are eligible to take part in the study if you:are female and aged 18-65 yearshave a BMI of 25-35kg/m2 (BMI means Body Mass Index - we will measure this for you)have not been dieting within the last monthhave not lost more than 5%of your body weight in the past yearhave not increased your physical activity levels in the past 2-4 weeks or intend to modify them during the studyunderstand and are willing and able to comply with all the study procedures and restrictions, including following the healthy eating adviceare able to eat most everyday foodshabitually consume three regular meals a day (i.e. breakfast, lunch and dinner)provide written informed consentExclusion criteriaSignificant health problems (e.g. hypercholesterolaemia, diabetes, gastrointestinal disorders)Use of medication or supplements known to affect appetite or weight within the past month and/or during the studyPregnant, planning to become pregnant or breast feedingHistory of anaphylaxis to foodKnown allergies or intolerance to foods and/or to the study materialsParticipants with abnormal eating habitsSmokers and those who have recently stopped smoking (less than 9 months ago)Participation in another research study or having received an investigational drug/product within 30 days of the screening visitParticipants receiving systemic or local treatment likely to interfere with the evaluation of the study parametersParticipants on specific food avoidance dietsParticipants who work in appetite or feeding-related areasWhat will happen to me if I decide to take part in the study?You will be required to consume the drink three times a day, i.e. before each main meal, for the duration of 4 weeks. There are no known side effects or risks associated with the drink. The study will also involve four visits (one screening session and three test sessions) to the OxBCNH at Oxford Brookes University, Gipsy Lane Campus. The three test sessions will take place over four weeks.Screening sessionThe screening session will last approximately 45 minutes. During this session, you will:be asked to sign a consent form and fill in a health questionnaire have your height, weight, waist and hip circumference and body composition measuredcomplete questionnaires about your eating habits, food preferences and responsiveness to foodprovide details of your dietary intake for the previous dayTest sessionsFor each of the three test sessions, you will need to visit the OxBCNH following a 10-12 hour overnight fast. These visits will take place at the beginning of the study, at the end of week 1 and at the end of week 4.Each test session will begin between 7am to 9am on week days and last approximately two hours. Each session will involve:Measurements of hunger, appetite, thirst and side effects (if any, of the test drink) at three different time pointsConsumption of the test drink or placebo (a powder dissolved in 200ml of water)Consumption of an ad libitum meal (breakfast cereals, toast, yoghurt, fruit, tea or coffee) – this means that you can consume as much breakfast as you would likeMeasurements of weight, waist and hip circumference and body compositionDietary intake recall for the previous dayMeasurements of mood, cravings, responsiveness to food and gastrointestinal (GI) symptoms172783512065Test session flowchart00Test session flowchart25622255176520Study Flow Chart400000Study Flow Chart25622255176520Study Flow Chart400000Study Flow ChartArrive at the OxBCNHMeasurement of weight, waist and hip circumference and body compositionMeasurement of hunger, appetite, thirst, nauseaConsumption of the test drink/placeboMeasurement of mood/well-being, cravings, responsiveness to food, GI symptomsMeasurement of hunger, appetite, thirst, nauseaAd libitum breakfastMeasurement of hunger, appetite, thirst, nauseaDietary intake recall (for the previous day)In addition to the test sessions, participants will be asked to provide two further dietary intake recalls (by telephone where appropriate) during weeks 2 and 3.The total time spent in the sessions (i.e. screening session and three test sessions) is approximately 9 hours 45 minutes.How to prepare for each test sessionYou need to fast overnight (approximately 10-12 hours) – this means no food or drink, although you are allowed to drink water in moderation.For example, if you start your test session at 8.30 am, you need to stop eating/drinking (apart from water) at 8.30 pm the previous evening.On the day of your session, please wear loose, comfortable clothing where outer garments and footwear, including socks and stockings, can easily be removed.What are the possible benefits of taking part?The study will provide valuable information that will be used to help people manage their weight through portion size control and increased satiety (feeling of fullness).You will receive information about your body composition measurements.You will receive healthy eating advice.You will receive ?50 of Amazon vouchers on completion of the study.Will what I say in this study be kept confidential?All information collected about you will be kept strictly confidential (subject to legal limitations).All records will be coded and will only be available to the researchers involved in the study; your name will never appear in any published work.All data will be securely stored at the University for a minimum of 10 years in accordance with the University’s policy on academic integrity.You are free to withdraw from the study at any time, without giving a reason, and to withdraw any unprocessed data previously supplied.What should I do if I want to take part?If you want to take part in this study, please contact:Ify Achebeor Hannah BrennanOxBCNHOxBCNHOxford Brookes UniversityOxford Brookes UniversityGipsy Lane CampusGipsy Lane CampusOxfordOxfordOX3 0BPOX3 0BPEmail: iachebe@brookes.ac.ukEmail: hbrennan@brookes.ac.uk Tel: 01865 483283Tel: 01865 482868What will happen to the results of the research study?At the end of the research, the results will be included in a detailed report submitted to the funding body (OptiBiotix Health Plc). No information about individual participants will be included in this report and it will not be possible to identify you. In addition, it is anticipated that some results may be published in peer-reviewed journals and presented at meetings and conferences. Participants will not be identified in any publications. Who is organising and funding the research?This research is being conducted by the Oxford Brookes Centre for Nutrition and Health, Department of Health and Social Care, Faculty of Health and Life Sciences and is being sponsored by OptiBiotix Health Plc ().Who has reviewed the study?This study has been approved by Oxford Brookes University Research Ethics Committee (UREC). Any concerns about the conduct of the study should be referred to the Chair of UREC on ethics@brookes.ac.uk.Contact for further InformationIf you have any questions regarding this study, you can contact either:Dr Helen LightowlerDr Miriam CleggDr Sarah HillierOxBCNHOxBCNHOxBCNHOxford Brookes UniversityOxford Brookes UniversityOxford Brookes UniversityGipsy Lane CampusGipsy Lane CampusGipsy Lane CampusOxfordOxfordOxfordOX3 0BPOX3 0BPOX3 0BPEmail:hlightowler@brookes.ac.uk Email: mvlegg@brookes.ac.uk Email: sarahhillier@brookes.ac.ukThank youThank you for your interest in this study and for taking the time to read this information sheet.Date: April 2017 ................
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