Pre-Screening: Subjects will first undergo a pre-screening visit with the PI. The PI will go
over the COVID-19 screening as well as the study screening for inclusion and exclusion
criteria. Subjects will be given information regarding the study details, location of the
study, and parking during this pre-screening visit as well.
Visit 1: This session will take place at the Exercise Physiology Laboratory (Prillaman 1102 -
Kennesaw State University) and subjects will be asked to arrive fasted (8-10 hours). Subjects
will be informed of the purpose, risks, and benefits of the study. They will be asked to
review and sign this consent form. Subjects may ask questions at any time. They will then
complete a Health History Questionnaire (HHQ) consisting of medical, physical activity, diet,
and supplementation history. Following completion of this consent and the HHQ a member of the
research team will take subjects to assess height, weight, and body composition (assessments
described below). Immediately following the body composition assessment, they will be asked
to fill out a series of questionnaires. These questionnaires will be electronic and will
require subjects to use a computer as well as applications on their phone (surveys and
applications described below).
A member of the research team will describe how to use the applications and computer
programs: 1) Cronometer (for dietary tracking); 2) MyGiHealth (for GID tracking); and 3)
SurveyMonkey (for GID tracking and supplement compliance tracking). Once subjects have
completed all surveys a member of the research team will then distribute their first 30 day
allotment of supplement (blinded, randomly assigned enzyme or placebo - both are 200 mg per
pill) and provide subjects with instructions on how to take the supplement (3 times per day -
right before a meal - for example right before breakfast, lunch, and dinner). They will then
be informed on how to track their GID and diet throughout the 30 days of supplementation
(described below). Lastly, subjects will be given their return date for Visit 2 and work with
the research team member on a time that works for them.
Visit 2: Subjects will return to the lab for Visit 2 following 30 days of supplementation.
During visit 2, they will have their body composition reassessed, as well as complete all GID
surveys as they did during Visit 1. Further, a member of the research team will ensure that
they completed all proper tracking of diet and GID during the 30 day supplementation period.
Subjects will then work with the research team member to determine a Visit 3 date. Visit 3
will be at least 7 days after Visit 2.
Visit 3 and Visit 4: Visits 3 and 4 will be similar to Visits 1 and 2, respectively. However,
subjects will not complete the informed consent form again and will not have to
download/install the applications, as they will have completed this during Visit 1. During
Visits 3 and 4, they will first have their body composition reassessed and fill out
questionnaires (GID) (same as Visit 1 and 2). Further, subjects will be asked to take the
supplement they did not receive during the first 30 days, for 30 days following Visit 3
(still blind to both the participants and research team). Subjects again will be asked to
track their diet and GID during the 30 days of supplementation between Visits 3 and 4 (see
tracking below). Following completion of Visit 4, subjects will receive their body
composition results from visits 4.