What are the risks and discomforts?
The study requires 4 blood draws. A needle will be inserted into a vein and blood will be withdrawn for lab tests by a trained phlebotomist.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).
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.
What are the benefits to me?
You will have free food for 4 weeks. Through participation in this study, you will also contribute to the advancement of knowledge about how weight, blood sugar, and nutrition affect immunity.
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 HNRU 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.
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 or if you don’t follow the diet. Also, if the research coordinator feels that it would be in your best medical interests to withdraw from 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 gift card to a grocery store of your choice upon completion of the study. Your parking and transit costs will be covered for participating.
Will my information be kept private?
During the study we will be collecting health data about you. We will do everything we can to make sure that this data is kept private. No data relating to this study that includes your name will be released outside of the study researcher’s office or published by the researchers. Sometimes, by law, we may have to release your information with your name so we cannot guarantee absolute privacy. However, we will make every legal effort to make sure that your health information is kept private.
The study staff may need to look at your personal health records held at the study doctor’s office, and/or kept by other health care providers that you may have seen in the past (i.e. your family doctor). Any personal health information that we get from these records will be only what is needed for the study.
During research studies it is important that the data we get is accurate. For this reason your health data, including your name, may be looked at by people from the University of Alberta auditors and members of the Research Ethics Board.
After the study is done, we will still need to securely store your health data that was collected as part of the study. At the University of Alberta, we keep data stored for 5 years after the end of the study.
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 Janis Cole (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.