Information brochure

Information brochure

Stippeneng Arboretumlaan Contact Research team: Lucian van Belzen (MSc student) Dr. Sanne Boesveldt Elbrich Postma Prof. Dr. C. de Graaf Contactperson: Lucian van Belzen Division of Human Nutrition, Wageningen University frodio@wur.nl Testing location: Restaurant of the Future (building 115) Stippeneng 2 6708 WE Wageningen 115 Futurum/Impulse (Restaurant van de Toekomst) Stippeneng 2 6708 WE Wageningen 307 Biotechnion Bomenweg 2 6703 HD Wageningen 113 112 Ede Arnhem /Utrecht A12, afslag 24 NS-station Ede / Wageningen / Railway station Kielekampsteeg 114 120 Bornse Weilanden Vijfde Polder 119 121 122 De Elst 123 118 Akkermaalsbos 115 Bornse- steeg 117 116 109 107 101 100 104 102 Wageningen Campus 103 Droevendaalsesteeg Nijenoord Allee Bronland Plantage Hoge Steeg 130 De Bongerd sportvelden/ Sportfields Mansholtlaan Bennekom / Ede 201 Hollandseweg Haarwal Nieuwe Kanaal Binnenhaven Kortenoord Kortenoord Geertjesweg 537 534 Haarweg Marijkeweg Allee Lawickse Allee Ritzema Bosweg Diedenweg Bevrijdingsstraat 406 Duivendaal Rooseveltweg Churchillweg A50 Renkum Arnhem / Nijmegen A15 Rhenen / Tiel Lawickse Allee Costerweg 425 Nieuwstr. 362 Gen. Foulkesweg 320 316 313 309 De Dreijen 351 312 308 307 304 Niemeijerstr. Veerweg 302 1

Preface This brochure contains information about the aim and the setup of the Frodio study. In this brochure is described what we expect of you as participant during the study, and what you can expect of the research team. The research will be executed by the division of Human Nutrition of Wageningen University. We kindly ask you to read this brochure carefully before you decide to participate in the research. The research consists of 4 sessions of approximately 15 minutes per session and takes place from 23 to 26 November 2015. Thank you for your interest in this study. We hope to meet you during the research! If you still have questions after reading this brochure or are interested in participating in the study, please contact us! Kind regards, Lucian van Belzen On behalf of the research team 2

Frodio Aim of the research The aim of the Frodio study is to determine the effect of different products on thirst. You are eligible for participating in this research when you: are a man or woman between 18 and 55 years old (born between 27-11-1959 and 09-11-1997) are in good general health (this will be checked by filling in a questionnaire) have a normal smell and taste function are not oversensitive or allergic to flavours are not pregnant/have the intention to become pregnant/are currently breastfeeding are not an employee of the Human Nutrition Department Before the research Information sessions and written consent Before the study starts we will organise information sessions. Here, the researcher explains the entire research setup and there is room for you to ask questions. When you want to participate you can directly sign an informed consent form (see appendix 1), whereby you confirm that you want to participate in the study. You can also come back to the University later to do this. When you have signed the informed consent form you will get a questionnaire to fill in. Based on the information that is obtained from the questionnaire it is decided if you are included for participation. When you meet the inclusion criteria (see page 3) we will make an appointment for the four testing sessions. During the testing sessions you will taste and evaluate food products. The tasks are explained in detail below. The study itself Testing sessions and location The research will take place on four consecutive mornings, from 23 to 26 November 2015, and will consist of four short sessions of approximately 15 minutes in the Restaurant of the Future between 8:00 and 12:30. Measurements Taste tests: You will taste food products (lemonade/water/popsicle) and evaluate the products on different aspects by a questionnaire on the computer. All products are suitable for consumption and are registered and approved by the Food and Consumer Product Safety Authority. Saliva collection: Before and after consumption of the product we will collect your saliva before and after the consumption of the product, by spitting it into a container for one minute. 3

What is further expected from you We kindly ask you to not drink anything 3 hours before the testing session. By not drinking, we mean the consumption of any kind of beverage. Drinking water, lemonade, juice, coffee, tea, yoghurt drink, breakfast drink or any other beverage is not allowed for 3 hours before the start of the testing sessions. Because the study will take place in the morning you can chose to not drink after waking up. When you normally have breakfast drinks in the morning, you are kindly requested to breakfast with a solid product, like bread or crackers. Possible advantages and disadvantages when participating Since Frodio is a research study whereby you will receive food products that are commercially available and are considered safe there is no reason to assume that consumption of these products can be of risk. Also the other procedures in this study are of no risk. You will contribute to scientific research. Participating in the study will have no direct health benefits for you. Independent physician For every scientific research an independent physician is assigned. An independent physician is a medical doctor who is not involved in execution of the study. The independent physician can be consulted for questions that are related to the research and which the participant does not want to discuss with the researchers. For research by the division of Human Nutrition this is dr. J.J. van Binsbergen (practitioner in Brielle). If you have questions about the study that you do not want to discuss with the research team you can call Dr. van Binsbergen by telephone (number: 0181 412155) on working days between 8:00 AM and 10:00 AM. You will hear a menu where you have to choose option 2 `voor overige zaken ( for other matters ). The assistant will write down your details and Dr. van Binsbergen will contact you. You can also ask questions by emailing to j.vanbinsbergen@outlook.com. We kindly request you to tell the assistant or note in the email the name of the study. Compensation You receive a financial compensation of 15,- in the form of VVV vouchers. Furthermore, you will contribute to scientific research. Quitting the research You can quit your participation in the study at any time. When you decide to quit before the study has ended you do not have to provide a reason for this. The data that are already collected will be used for the results of the research. What happens with your details All details that will be collected will be handled carefully and saved according to the Wet Bescherming Persoonsgegevens. This means that personal data and research data will be separated from each other and that all research data will be saved under code. All researchers that are involved in the research have signed a confidentiality agreement. Results Results of this research will be submitted for publication in a scientific journal whereby the obtained information cannot be traced back to individual persons. We cannot give you information regarding your individual results. The data will be kept for a period of 15 years after the results of the research are published. 4

Approval by the Medical Ethical Committee The research is positively evaluated by the Medical Ethical Committee of the Wageningen University. Because there is no risk associated to the research the Medical Ethical Committee of Wageningen University gave exemption for the test person insurance. Written consent When you participate in the research we kindly ask you to sign an informed consent form. With this written consent you declare that you are sufficiently informed about the aim and the setup of the research, that you know what is expected from you and that you give your permission for participation. Questions? If you have any further questions, please contact us: Lucian van Belzen, e-mail: frodio@wur.nl 5

Appendix 1: Written consent for participation: Frodio Research title: Frodio Period: 23/24/25/26 November 2015 Name and address: Wageningen University Division of Human Nutrition Biotechnion, Bomenweg 2, 6703 HD Wageningen Phone: 0317-482111 Researchers: Lucian van Belzen (MSc student) Dr. Sanne Boesveldt Elbrich Postma Prof. Dr. Kees de Graaf This research is positively evaluated by the Medical Ethical Committee of Wageningen University. Aim and design of the research, information about the inclusion criteria, confidential use of personal data and research data, insurance, independent physician and possible risks are described in the information brochure. Declaration Undersigned declares to be sufficiently informed about the research, either verbally and written and confirms to have understood this information. Undersigned knows that he/she can quit the study at any time also after giving consent and without reason. Undersigned is willing to participate in the research. Name : Address: Postcode: Place of residency: Bank account number: Phone number by day: Phone number by Mobile phone number: night: Date: Signature participant: The researcher declares herewith that abovementioned volunteer is informed adequately about the abovementioned research and is willing to answer questions. Date: Signature researcher: 6