Below are the most common questions we are asked about the study. Please contact us if you don’t see your question listed.
When does the study start?
The study is “live” but there is no singular official start date for all participants. Stated similarly, we are onboarding new participants into the study on a rolling basis. Given the time requirements and logistics of the study (such as lab availability in light of social distancing requirements), we will evaluate enrollment on a week to week basis.
If you meet all study requirements (“inclusion and exclusion criteria“), and are interested in participating, we can work together to find a mutually-acceptable start date for you to join the study.
I meet all criteria but one. Can I still participate?
Oh no! So close …. but unfortunately, no. That single item may compromise study results and validity.
That said–if the situation is temporary and you may qualify within the next several weeks–please let us know! We can remain in touch with you and mutually determine if you are able to participate before we conclude the study.
Please contact us if you have any questions about whether or not you may qualify to participate.
Will I be compensated for my participation?
We are not providing cash compensation or direct payments of any type. However, there are significant benefits to full participation in the study (the total retail value of these benefits is over $3,000).
If I begin the study, can I pause my participation?
Unfortunately, no. Because the study is continuous, we would have to eliminate your data from statistical analysis if you are unable to participate for the entire 16-week study duration.
Are the number of participants limited?
Yes. We are limiting participation given the size of the investment we are making in each participant (time, resources, and cost).
What if I miss a day (or two) of the supplement?
Although that’s not optimal from a study perspective, if that happens, we just ask that you notify a member of the research team immediately to discuss options to help you remain in the study. We can generally remedy this situation if it is an isolated incident.
Can I reschedule my lab visit?
Possibly–it depends on which visit it is, and it also depends on the number of days away from “optimal” it is. For example, it would be easier to reschedule V1 if necessary because it is literally day one of the study. However, if you are referring to V2 or V3, that is potentially problematic, because we have to obtain data for the same time periods for each participant (i.e., V2 is on/about day 56 of the study). If the number of days away from “56” in this example is 1-2 days, we may be able to accommodate that, but it depends on other factors such as research staff and lab availability.
If you are participating in the study and there is an emergency or extenuating circumstance that may result in your need to reschedule a lab visit, please inform a member of the research team as soon as possible.
Can I share my lab and test results with my primary care physician?
Absolutely! The data you will have, on completion of the study, will be a valuable element of your ongoing health and wellness goals and can be directly leveraged by any of your health care providers.
Is this study approved?
The design of this study, from the objectives to specific procedures, was submitted for approval to the Kennesaw State University Institution Review Board (IRB). IRBs are groups of qualified professionals who review research study applications for appropriateness and, in particular, safety (for all involved–from members of the research team to participants). We have received IRB approval to proceed with the study.
How will my data and personal information be protected?
You will be assigned a unique study identification number (SID). All study records in either hard copy or in electronic format will contain only the SID and no other identifying or personal data. All data collected from you will be considered highly sensitive and held in strict confidence. The Primary Investigator will maintain the SID file that matches participants with their unique SIDs. Without this file, it will not be possible to associated stored data with the individual from whom it was obtained.
Do I get to select which supplement group I’m in ?
Unfortunately, no. This is a “blind” study, which means that no participant will know to which group they were assigned until after the study is completed (studies are performed blind to eliminate the potential influence on outcomes).
What are DHA and EPA?
DHA and EPA are two specific types of omega-3 polyunsaturated fatty acids. Based on several decades of research, the primary health benefits associated with omega-3 ingestion derive from DHA and EPA. DHA is an acronym for docosahexaenoic acid and EPA is an acronym for eicosapentaenoic acid. Please visit About Omega-3s to learn more about DHA, EPA, and other related topics.
Why is it important for me to complete the entire study?
If you drop out of the study before full completion, unfortunately, we cannot use any of your data in our statistical analyses. Also, research studies are expensive to conduct, and we have a limited budget; if you drop out, any investment we make for your participation will be lost.
You always have the right to terminate your involvement at any point. We also appreciate that there are unforeseen circumstances that may arise.
However, if you are uncertain of your commitment to complete the entire 16-week duration of the study, please make this clear to us before your participation in the study begins so that we make mutually agree on the best path forward.
What is the relationship between Vitalyon LLC and KSU?
Vitalyon LLC is a wellness business that has no affiliation with Kennesaw State University. Vitalyon’s founder and CEO is Brent Uken, this study’s Primary Investigator. Mr. Uken is using his business, founded prior to his affiliation with KSU, to privately fund certain elements of this research study, such as the development of this website and the platform we are using to automate email communication with you.
Vitalyon offers education, coaching, and fitness-related consulting services in the fields of strength, conditioning, personal training, sports performance, and nutrition. To be clear, there is absolutely no commercial aspect to this study and there is no financial arrangement between Vitalyon and KSU.
As noted on the Benefits site page, Mr. Uken will be providing fitness-related consultation services to every participant who completes the 16-week study. This consultation will be provided by Mr. Uken in his role as CEO of Vitalyon and this consultation will be provided at no cost to you.
Couldn’t find your question in the list above? Use the “CONTACT” button below to reach out to us so that we can help you find an appropriate answer.