Volunteers needed for a functional nutritional bar study
Recruitment is Now Closed
TO PARTICIPATE IN THIS STUDY, YOU MUST BE:
Healthy and 18 years
or older
Employed as a member of the Durham Regional Police Services
Free of current metabolic diseases, and not at risk of liver disease, kidney diseases or a seizure disorder
This will be a 6 week open-label, interventional study
✅ It will examine the effect of a nutritional functional bar, Mission Focus, and how it can fit within your busy schedule.
✅ Participants will receive a free box of the Mission Focus bars. This study will be 3 online sessions where questionnaires will be completed by each participant on their own time.
To View The Consent Form
Want to Participate?
Here Are 2 Options to Get Started:
OPTION 1:
If you have questions, book a Calendly appointment with the research team here:
Recruitment is Now Closed
No name or phone number required: you will be provided with a time, date and phone number to call.
OPTION 2:
If you are ready to get started, fill out this form, to request the electronic consent form.
Recruitment is Now Closed
OPTION 1:
If you have questions, book a Calendly appointment with the research team here:
No name or phone number required: you will be provided with a time, date and phone number to call.
OPTION 2:
If you are ready to get started, fill out this form, to request the electronic consent form.
Full name and email are required.
FAQ
Why are we doing this study?
Law enforcement officers, and personnel are often exposed to high stress activity such as workload stress, demanding schedules, and continuous multitasking, all of which can affect overall wellbeing. A balanced diet with high quality nutrients is essential to support one’s well-being, especially during times of stress. However, high stress jobs on a frequent basis can affect eating patterns and demands. People who are feeling stress could lack the motivation to prepare a well-balanced meal, may skip meals all together or crave comforting foods such as highly processed snacks, which are low in quality nutrients. This research study will provide insight into the feasibility, and acceptability of how a functional nutritional food bar could support well-being in your work environment.
What is the purpose of this study?
The purpose of this study is to develop a tasty and functional food bar that tests feasibility, acceptability and overall well-being in a stressful work environment.
Who can participate?
You must be employed as a member of staff at the Durham Regional Police Services (DRPS) and aged 18 years or older, free from metabolic diseases such as type I diabetes, not be pregnant, not be planning to become pregnant, not be breastfeeding, not suffer from food allergies, not have current risk of liver disease, kidney disease and/or a seizure disorder. You must be capable and willing to provide consent and, understand study instructions and study plan, as well as read English fluently. About 325 people will participate in this study.
What will be asked of you in this study?
If you choose to participate, you must electronically sign the study consent form, which will be reviewed by the investigator who will confirm your eligibility to participate. If you are ineligible to participate you will be sent an email. If eligible to participate, a signed copy of the completed consent from will be emailed directly to you.
You will receive through internal courier your study box. A study box contains 4x boxes of 20x of Mission Focus nutritional bars (60 bars for study and 20 bars as study benefit), a study ID code, password and study instructions.
This is an online trial, where you will be asked to consume a nutritional bar, Mission Focus, every day for 6 weeks and participate in 3 online sessions (Day 0, Day 8 and Day 42). The online sessions will take place during off-work hours at a location of your choosing. All online sessions are comprised of short questionnaires that will assess your overall well-being, perceived stress and executive functions, as well as a your demographic, and potential side effects.
What will the experimental sessions look like?
Day 0: Completion of an online baseline questionnaire (~10-15 minutes), which includes demographic questionnaire, WHO-5, webexec, and PSS-10.
Day 8 & 42: Completion of a study questionnaire (~10-15 minute), which includes WHO-5, webexec, PSS-10, side effect monitoring, and feedback questionnaire.
What are the questionnaires measuring?
Demographics questionnaire: You will complete an online demographics questionnaire including age, occupation in the law enforcement world, global health questionnaire at day 0 (before thanking the bar).
WHO-5: The 5-item World Health Organization Well-Being Index is a self-report measure of subjective wellbeing. The WHO-5 is among the most widely used questionnaires assessing subjective well-being by investigating positive mood, vitality, and general interest. This questionnaire will be evaluated at days 0, 8 and 42.
Webexec: The Web-based executive function questionnaire (webexec) is a questionnaire that is designed to subjectively assess experiences of problems, with regards to different aspects of executive function. This questionnaire will be evaluated at days 0, 8 and 42.
PSS-10: The Perceived Stress is a measurement designed to be able to evaluate the degree by which situations in people’s lives are perceived as stressful. The PSS-10 is one of the most widely used and validated psychological instruments for measuring the
perception of stress. This questionnaire will be evaluated at days 0, 8 and 42.
Feedback questionnaire: This short questionnaire contains questions about the study compliance, as well as your thoughts on Mission Focus snack bar, as well as your perceived thoughts on the efficacy of this bar. This questionnaire will be evaluated at days 8 and 42.
Safety assessment: A checklist of common side effects associated with ingestion of functional food (e.g., headaches, nausea, dizziness) will be monitored throughout the 6-week intervention period. This questionnaire will be available in study portal at all times.
Participants will also have Dr. Delphie Dugal-Tessier’s email and phone number if they wish to report adverse effects at any time during the study. Furthermore, there will be a chat option to directly and anonymously contact Dr. Dugal-Tessier to report any side effects. You are free to drop out from the study at any time and for any reason, in particular if they undergo uncomfortable side effects. Even though this questionnaire is available at any time, this questionnaire will also be evaluated at days 8 and 42.
Where will be the questionnaires?
All questionnaire will be in the study portal
What do I need to access the study portal?
Only participant who electronically sign the consent form, as well as have a signed copy
by the investigator will receive a study box. In the study box, the participant will receive
the link to the study portal and study ID-code and password to have access to the study
portal.
What does the study bar contain?
Study ingredients:
- Fruit puree (apple/plum/apricot) ~40g
-
Date paste/date puree (dates, sunflower oil, water, concentrated lemon juice) 15.4g
-
Organic quick oats 3g
-
dried cranberries 5g
-
dried blueberries 1.5 g
-
Granulated sugar 3.3g
-
Organic coconut flour 1.5g
-
maple syrup 2.5g
-
Guar gum 300mg
-
Maltodextrin 3g
-
Natural flavours 200mg
-
Vitamin C (Ascorbic acid) 500mg
-
Vitamin B6 (Pyridoxal-5-phosphate) 25mg
-
Taurine 1g
-
Magnesium (Glycinate) 30mg
-
Acetylcarnitine 3g
-
Organic Black Maca Powder (Lepidium meyenii root) 500mg
-
Choline Bitartrate 500mg
-
L-theanine 250mg
-
L-tyrosine 2.5g
-
Maritime pine (Pinus pinaster 75% procyanidines) 200mg
g: grams; mg: milligrams
Are they risks and discomforts associated with this study?
There are minimal harms associated with participation in this research. There may be side effects from the nutritional bar from this study. The side effects we know about now may include:
- Digestive upsets such as diarrhea, and
- Stomach cramps.
If you experience these side effects, please discontinue ingestion of Mission Focus. There may be other side effects that are not known at this point. You should disclose all side effects and withdrawal from the study at any time by completing an online form (link provided in study portal). Side effect monitoring will be asked on Day 8 and Day 42, however, a check-list of side effects will be available to you throughout the study in the study portal. If a side effect appears to be significant, a pop-up message will advise you to immediately discontinue the ingestion of Mission Focus. A chat option will also be readily available to you to anonymously and directly contact the study investigator. If symptoms are severe and does not subside after the discontinuation of Mission Focus, you are advised to consult your family physician.
Immediately visit an Emergency Room (ER) if you experience symptoms such as:
- breathing difficulty
- persistent, sever chest pain
- confusion, and/or
- loss of consciousness
After your condition improves, immediately contact the study investigator to report side effects.
Some participants may find that the questions are sensitive and may cause emotional discomfort. You may choose the option “I prefer not to disclose” to specific questions. This study requires 3 online sessions, to a maximum of 15 min per session, which may constitute a significant time commitment on your part.
If you believe you are struggling with issues related to your mood, stress and anxiety you should contact your health care provider. In your study box you will be provided with information to seek help such as the Durham Distress Center https://distresscentredurham.com, distress line: 905-430-2522 & 1-800-452-0688.
Do I get compensation for a study related injury?
No compensation or reimbursement will be provided for medical treatment in the rare or unlikely event of a research-related injury.
What are the benefits for participating in this study?
Being in this study may or may not lead to any direct benefit. Information gathered from
this study may provide benefit to society.
What is the compensation for participating in this study?
You will not receive any monetary compensation for your participation in this study. Each study box will contain an extra box of Mission Focus at no cost (20x bars total). This box is not study related and is for your use after the end of the study, if you choose.
How will my privacy be protected?
Your privacy will be respected at all times, except where disclosure is required by law. As part of this research, the investigator will collect the results of your study-related tests and procedures. In this study, all raw data will be stored using an alphanumeric coding system. This coding system (study ID code) will not be linked to your name or other identifying information such as your date of birth; as such, there will NOT be a master link linking names and study ID code. The only records bearing your name will be the consent form, which will be stored in a locked cabinet at Staterra, and any personal information that you may voluntarily provide during conversation with the investigator. All consent forms will be destroyed by Staterra immediately after the completion of the
study.
Who will have access to your data?
Some persons may need to see the study records in order to monitor the research and verify the accuracy of the study data, including:
- a limited number of representatives from the study sponsor (namely its monitors
and auditors), - the research ethics review board – Advarra IRB (an independent ethics committee that reviewed the ethical aspects of this study to help protect the rights and welfare of study participants),
- government regulatory authorities including Health Canada, the US Food and Drug Administration (FDA) and other foreign regulatory agencies.
How will the data be protected?
Data which includes your study ID, and answers to the online questionnaires, will be kept at Staterra in on an offline password-protected computer and only the people mentioned above will have access to the de-identified data. The data collected in this study will be published in scientific journals, but your identity will not be disclosed. Data will be kept indefinitely.
By signing this information and consent form, you consent to the collection, access, use
and disclosure of your information as described above.
How is this study funded?
Innovative Solutions Canada (ISC) Grant – sponsored by the Royal Canadian Mounted Police (RCMP).
Is there a conflict of interest?
The researchers from Staterra Inc. will benefit from your participation in this study. The results of this study will be used to promote the innovation of the functional food bar. You will not receive monetary profit or compensation from the commercialization of this research-based nutritional bar. The data collected in this study may set Staterra Inc apart in the marketplace and help show the safety and efficacy of Mission Focus on overall well-being.
Is there a cost in participating in this study?
There is no cost to you, your private medical insurance (if any), or the public health insurance plan, for study procedures.
Is there an alternative to participating in this study?
This research study is for research purposes only. The only alternative is to not participate in this study.
Is this study voluntary and can I withdraw my participation?
For the entire duration of the study, it is fully understood that you may refuse to participate or withdraw from the study at any time and without question. It is also fully understood that you can withdraw from the study at any time, as well as withdraw all study information. This option will be available to you in your own study portal.
The Investigator or the sponsor can stop your participation at any time without your consent for the following reasons:
- If it appears to be medically harmful to you;
- If you fail to follow directions for participating in the study;
- If it is discovered that you do not meet the study requirements;
- If the study is canceled; or
- For administrative reasons.
As an employee of the Durham Regional Police Service, you are under no obligation to participate in this study. You may withdraw from the study at any time and for any reason, and neither your decision to participate in the study, nor any decision on your part to withdraw, will have any effect on your performance appraisal or employment at this institution. You may refuse to participate or you may withdraw from the study at any time without penalty or anyone blaming you.
Whom do I contact about this study?
During the study, if you experience any medical problems, suffer a research-related injury, or have questions, concerns or complaints about the study such as:
- Whom to contact in the case of a research-related injury or illness;
- Payment or compensation for being in the study, if any;
- Your responsibilities as a research participant;
- Eligibility to participate in the study;
- The Investigator’s or study site’s decision to withdraw you from participation;
- Results of tests and/or procedures;
Please contact the Investigator at the telephone number (1-833-545-2643) or email:
delphie@staterra.ca
If you seek emergency care, or hospitalization is required, alert the treating physician that you are participating in this research study.
Is this study ethically approved?
Yes, this research project has been approved by the institutional review board Advarra IRB, reference number: Pro00064907.
Who do I contact if I have ethical questions or concerns?
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, contact:
By mail:
Study Subject Adviser
Advarra IRB
6100 Merriweather Dr., Suite 600
Columbia, MD 21044
or call toll free: 877-992-4724
or by email: adviser@advarra.com
Please reference the following number when contacting the Study Subject Adviser: Pro00064907.
If I’m interested in participating, where do I sign up?
You can sign up for this study by filling out the form on the top of this page to request the electronic consent form. Your full name and email are required, however, either will be needed in the study or be link to any of your data.
If I’m interested in participating, but I have a few questions?
If you have questions, you can book a Calendly appointment with the research team by following option 1 at the top of this page. No name or phone number required: You will be provided with a time, date and phone number to call.
An institutional review board (IRB) is an independent committee established to help protect the rights of research participants. If you have any questions about your rights as a research participant, and/or concerns or complaints regarding this research study, contact: By mail:Study Subject Adviser, Advarra IRB, 6940 Columbia Gateway Drive, Suite 110 Columbia, MD 21046 or call toll free: 877-992-4724 or by email: adviser@advarra.com. Pl