What are the risks and discomforts?
The study requires 4 blood draws and one IV. A needle will be inserted into a vein and blood will be withdrawn for lab tests by a trained phlebotomist. It is possible that you may experience mild pain, fainting, bleeding, bruising, and/or an infection at the insertion site. Bruising is common, but usually goes away after a few days. Infection, dizziness, and fainting are rare during this procedure. If you have a pacemaker or another electrical device in your body, you should not have a blood measurement because the blood measurement may prevent the device from working properly.
There is also a small possibility that you may experience an allergic reaction to a food (if you have a food allergy). Although, every effort will be made to reduce participant exposure to the food that they are allergic to, if exposure does occur, an epi-pen will be kept in the HNRU, and medical attention will be sought out (if needed). However, we cannot guarantee foods will not be in contact with priority allergens, so if there are any food allergies of your concern, you must need to be aware of this.
The X-ray dose associated with a total body scan is very low and safe for repeated measurements. With the exception of pregnant women, there are no known risks associated with DXA scans. Having a DXA scan does not make it unsafe for you to have other x-rays taken in the near future. You may ask the technologist to stop the test at any time without jeopardy to you. All information collected from your data base will be stored using your study identification study not your name.
There may be risks in this study that are currently not known. If we find out anything new during the course of this research which may change your willingness to be in the study, we will tell you about these findings.
Risk of exposure to COVID-19 with your participation includes exposure to others (research personnel and other participants) and increased time within our research unit. Measures undertaken to reduce this risk include ensuring all personnel and participants wear a mask, frequent hand washing (or use of hand-sanitizers) and limiting the unit capacity in accordance to campus guidelines. All hard surfaces and common touched areas are disinfected before and after each visit. Staff and participants will be screened for symptoms consistent with COVID-19, recent travels, and contact with others who are suspected or test positive for COVID-19. Additionally, all of the menu preparations will be done wearing a mask. If you become sick, or have any symptoms of COVID-19, you must inform study staff.
What are the benefits to me?
There are no direct benefits to participants. Through participation in this study, you will also contribute to the advancement of knowledge about how weight, blood sugar, and nutrition affect immunity. You will also receive meals for 4 weeks.
What will I need to do while I am in the study?
For all of the blood measurements, you need to make sure that you don’t have anything to eat or drink (except water) 9 hours before the measurement. Also, during the 4-week diet period, you need to eat only foods prepared by the study team for 4 weeks. The study coordinator will give you information about other beverages that you can drink outside of the study. You will need to record any food/drinks eaten or drank outside of the study in a food journal, given you to you by the study coordinator at the beginning of the study. Lastly, you will need to maintain your regular physical activity levels throughout the 4-week diet period. You will be also asked to follow food safety instructions of food handling and transportation. This is to ensure that the food provided to you remains safe to eat.
Do I have to take part in the study?
Being in this study is your choice. If you decide to be in the study, you can change your mind and stop being in the study at any time, and it will in no way affect the care or treatment that you are entitled to.
Can my participation in the study end early?
The research coordinator may withdraw you from this study if you don’t show up for your study visits without previous notice for rescheduling or if she feels that it would be in your best medical interests to withdraw from the study. We will be assessing compliance to the diet on a weekly basis and if the overall compliance below 90% is observed (including food consumed in addition to the menu), participants will be excluded before the end of the study. Incentives will be given only to participants who successfully complete their participation in the study.
Will I be paid to be in the research?
You will not be paid for participating in this study. However, to thank you for your time with the overall study, you will receive a $100 grocery store gift card upon completion of the study. Your parking and public transit costs will be covered for participating at the end of the study with additional grocery store gift card(s).
Will my information be kept private?
During this study we will be collecting information (or “study data”) about you. We will use the data to help answer research questions and we will share (or “disclose”) your information with others such as the study sponsor and other researchers. Your study data may also be shared with government departments involved in the approval of drugs for sale in a country. These departments are often called “regulatory authorities”. An example of a regulatory authority is Health Canada.
Below we describe in more detail how your data will be collected, stored, used and disclosed.
During this study we will be collecting data about you. Examples of the types of data we may collect includes your name, where you live, your ethnic background, your date of birth, your age, your health conditions, your health history, your medications and results of tests or procedures that you may have had. We will only look for and collect the information that we need do the research. We will get this information by asking you questions and doing the tests outlined in this form. We will also look at your medical chart (paper or electronic) held by the study doctor or other doctors you have seen (such as your family doctor).
The study data we collect which will include your name will be securely stored by the study coordinator during and after the study. We will also put a copy of this consent form in your clinical record, so that doctors you see in the future will know you were in the study. In Canada, the law says we have to keep the study data stored for at least 15 years after the end of the study. The study doctor/coordinator will not release your name to anyone unless the law says that they have to.
Your study data will be coded (with a number) so that it no longer contains your name, address or anything else that could identify you. Only the study coordinator and study doctor will be able to link your coded study data to you.
If you leave the study, we will not collect new health information about you, but we will need to keep the data that we have already collected.
What if I have questions?
If you have any questions about the research now or later, please contact the study coordinator Paulina Blanco (780-492-9506). If you suffer a research related injury – please contact the research coordinator at this number as well.
If you have any questions regarding your rights as a research participant, you may contact the Health Research Ethics Board at 780-492-2615. This office is independent of the study investigators.
The study is being conducted/sponsored by the Canadian Institutes of Health Research (CIHR). The Institution and study staff are getting money from the study sponsor to cover the costs of doing this study. You are entitled to request any details concerning this compensation from the Principal Investigator.