INFORMATION BROCHURE GLUCAM study The Blood Glucose and Insulin Responses After Drinking of Camel Milk December 2011 January 2012

Transcription

1 INFORMATION BROCHURE GLUCAM study The Blood Glucose and Insulin Responses After Drinking of Camel Milk December 2011 January 2012 Division of Human Nutrition, Wageningen University - 1 -

2 Contact information: Division of Human Nutrition, Wageningen University Abdulaziz Alangaree Telephone: abdulaziz.alangaree@wur.nl Research team: Abdulaziz Alangaree, BSc., Wageningen University Monique van Nielen, MSc., Wageningen University Ir. Anne Wanders, researcher, Wageningen University Prof. Dr. Ir. Edith Feskens, project leader, Wageningen University - 2 -

3 Preface Thank you for your interest in our study. This brochure has been designed to inform you about the GLUCAM study. It will tell you what you can expect from the study and the researchers if you decide to participate. This study is being conducted by the Division of Human Nutrition of Wageningen University and will take place during December 2011 and January If you are considering participating in this study please read this brochure carefully. If you are interested in this study you can contact us and we will make an appointment to screen you for this study. If you have any questions after reading this brochure, please feel free to contact us. With kind regards and on behalf of the research team, Abdulaziz Alangaree - 3 -

4 Camel milk Camel milk is traditionally claimed to have health benefits. Diverse animal, population based and human intervention studies state that camel milk is beneficial for people with diabetes. However, the mechanism is unclear. Camel milk contains less protein and lactose than cow milk. This difference may explain specific health benefits like glucose lowering effect of camel milk. The Food and Agriculture Organization (FAO) showed that the production of camel milk is rising. Since 2007, camel milk is available and produced in The Netherlands. Dutch camel milk does not differ from camel milk in Africa and the Middle East. It is known that the type of food determines blood glucose and insulin responses after consuming food. Foods causing a smaller increase in blood glucose level can be beneficial to diabetic patients, because they cause a smaller insulin response after a meal and in long term reduce mean blood glucose concentrations. Purpose of the GLUCAM study It is claimed that camel milk causes a lower increase in blood glucose level compared to cow milk. So, the purpose of this study is to determine the effect of drinking camel milk on blood glucose and insulin concentrations compared to drinking cow milk

5 GLUCAM study When and where The study will take place during December 2011 and January 2012 in the "Biotechnion" (Bomenweg 2, Wageningen). The study consists of 4 sessions (1 2 sessions per week), and will take 2.5 hours each between 8:00 and 13:00h. What is expected from you as a participant? The evening before the tests Since many things can affect blood glucose concentration, we ask you to choose a meal that you will consume on each evening prior to a session. Furthermore, we ask you to fast at least 10 hours before the test starts (e.g. if your appointment was scheduled at 8:00, please stop eating at 22:00 on the evening before the test day). You may have sugar-free coffee or tea until 23:00h on those evenings. Moreover, you may drink water until 1 hour before starting the test. Because of the fasting state, you may feel a little discomfort, but it will likely be reduced after ingestion of the test drink. Furthermore, we ask that you do not consume alcohol or engage in unusual vigorous exercise on the evenings before the tests. Fasting protocol summarised: Night before the session (screening or test day): After 22:00: only coffee, tea (without milk/sugar) and/or water. Nothing to eat. After 23:00: only water. Nothing to eat. Morning of the session (screening or test day): Drinks: only water. Nothing to eat. 1 hour before your appointment, and nothing to drink or eat. Test sessions There will be 4 separate sessions that you will attend as a participant in this study. The session will be scheduled to begin between 8:00 and 10:30h. Once you have sat down, warmed up your hands and relaxed, (about 15 minutes after arrival), 2 blood samples will be taken to measure your fasting glucose - 5 -

6 and insulin levels. Then, you will be given 1 of 4 test drinks, which are: bottled camel milk, camel milk powder solution, bottled cow milk and glucose solution (different drink for each session). Each drink contains 600ml, which you will be asked to drink within 10 minutes. To make it easy, the 10 minutes will be divided to 3 periods: the first 3 minutes, the next 3 and last 4 minutes, in each period you will drink 200ml. Each milk drink contains approximately 370kcal, the glucose solution contains 100kcal. In comparison; a normal breakfast in The Netherlands contains 310kcal. After the session is over, you will be given breakfast. Then, you are free to leave. During the test session we ask you to remain seated; you may bring music, your laptop and books. Taste of camel milk Camel milk and cow milk almost taste similar. You will have an opportunity to taste the camel milk during the screening visit. Blood samples Blood sampling will be held in a room which is equipped for this procedure. We will handle the blood samples with great care. During GLUCAM study, 2 methods of blood sampling will be done, which will be explained in the next paragraphs. Method 1: finger-pricks To determine blood glucose levels, 7 blood samples are needed each session, 1-2 drops of blood from a finger will be taken using a lancing device, which is a widely used method. To make it convenient to you, a different finger will be used at each time. At intervals of exactly 0, 15, 30, 45, 60, 90 and 120 minutes after drinking the test drink, a finger-prick will be taken. As a result of finger-pricks it is possible that you have very small wounds on your fingers, which will recover quite fast

7 Method 2: venous blood sample To determine blood insulin and amino acids concentrations, a standard venepuncture at the elbow will be taken. During the session, 3 venepunctures at 0, 30 and 75 minutes will be taken in one or both arms (depends on your preference). These samples are taken by an experienced and qualified nurse. In some cases, small bruises or feelings of dizziness may occur. During each test day, a maximum amount of 50ml of blood will be taken (a maximum of 200ml for the whole study), this will not lead to anaemia. In comparison, at a typical blood donation 500ml of blood is taken. How to participate in the study? The participants For this study we need 20 healthy volunteers between the ages of 18 and 35 years old. In this case healthy means that you have a normal body mass index (BMI) between 18.5 and 25 kg/m2. You can calculate your BMI by dividing your body weight (in kg) by the square of your body length (in meters): BMI = weight/(length x length). You can participate if you: do not have diabetes or any chronic diseases; do not smoke; have not lost or gained more than 5 kg and you have not used an energy restricted diet in the last two months; do not have an allergy or intolerance to lactose or milk. (People with lactose intolerance may experience abdominal pain, bloating, diarrhoea or nausea after drinking milk.) - 7 -

8 Financial compensation Upon completing this study you will be paid 100,-. Participation If you would like to participate in this study please contact us by or telephone to schedule a screening appointment. Screening In order to determine if you fit the criteria for this study you will be screened. This will be done by filling out a questionnaire, followed by measurements of height, weight and blood glucose (finger-prick). For this visit we ask that you wear light clothing, heavy clothing will put extra kilograms on your actual weight and may affect your BMI. Also, we ask that you come fasted; for fasting instructions, you will be asked to follow the instructions mentioned before (page 5). You will have an opportunity to taste the camel milk during the screening visit. The meeting will take approximately 20 minutes. Informed consent If you would like to participate in the study, you have to give your written informed consent before the screening procedure. By signing this form you declare that you understand this brochure and you are informed about the study objectives. Participation in other studies During the GLUCAM study we ask you not to participate in any other studies. Withdrawal from the study At any time, in the study, you can choose to withdraw for any reason. You do not need to provide the researchers with any reason for withdrawing. Any data you provided to the study will be used up to the point of your withdrawal. If you decided to prematurely withdraw from the study, you will be financially compensated based on the number of days you participated

9 Other important information Privacy The GLUCAM study has been granted medical ethical permission by the medical ethical committee of Wageningen University. The personal information collected during the course of this study will be kept confidential and is treated anonymous. All researchers involved in this study have signed a privacy agreement. Furthermore the individual who registered this study is registered with the College of Personal Data Protection under number m The blood samples from the venepunctures will be anonymously stored up till 5 years after publication. Study results The results of this study will be submitted for publication in an international scientific journal. In addition all subjects will receive a summary of the results. During the screening visit, if you have a high blood glucose level, you will be informed by us. Independent physician If you have any questions and/or concerns, you can contact the research team. However, if you have questions or concerns regarding this study that you do not want to discuss with the researchers, please do not hesitate to contact our independent physician. Independent physicians are not involved in the study. Contact information for the physician can be found below: Dr. J.J. van Binsbergen, GP Tel , (Mon-Fri: 8.00 and 10.00); j.vanbinsbergen elg.umcn.nl The assistant will record your contact information and which study you have questions about. Then, Dr. Van Binsbergen will contact you

10 Insurance This study is on a food product, which you could purchase yourself in a supermarkets and stores. Because of that we do not expect any side effects, there is no indication that an adverse reaction will occur unless you have a severe allergy to milk. If you have an allergy to milk, you are not allowed to participate in the study. Wageningen University has an insurance for all participants, as in accordance with the Law-Medical Research Involving Human Subjects. If you experience an adverse event from the study or if you believe you have suffered a medical consequence as a result of this study, you can contact the insurer directly and file a claim. However, your claim should be based on medical knowledge and furthermore it should be possible to reasonably show that the damages are indeed the result of the study. Additional information about terms and conditions of the insurance coverage can be found in the annex of this brochure. If you would like to see the entire policy, feel free to ask the research team. If you have any further questions about the study or participation, please contact us

11 Annex: Insurance details WHAT ABOUT INSURANCE? To cover any damage that you may suffer as a result of impairment to your health, which can be medically proven as being reasonably the result of the study, insurance has been taken out by Wageningen University for your benefit. This insurance complies with legal requirements, and offers coverage for damage up to a maximum of 450,000 per volunteer. However, maximum coverage for the whole group of volunteers participating in this study is 3,500,000 and maximum coverage for the whole group of volunteers participating in all studies performed at Wageningen University in the course of this year is 5,000,000. This damage has to become apparent during your participation in the study, or within 4 years after the end of your participation in the study. The insurance offers no coverage for damage: that due to the nature of the study, was certain or almost certain to occur; due to impaired health of the volunteer that may have appeared even if the volunteer had not taken part in the study; that results from a volunteer s totally or partially non-compliance with instructions; which occurs in offspring as a result of an effect of the study on the genetic material of the volunteers; in case of study of existing methods of treatment: damage that results from one of these methods; in case of study of treatment of specific health problems: damage that results from non-improvement or deterioration of these health problems. In the event you wish to submit a claim on this insurance policy, you are requested to report any damage as soon as possible to Gerling Konzern Allgemeine Versicherungs AG, direction for the Netherlands, The Netherlands, phone Full details on the insurance conditions are available for your information at the medical screening centre.