Effect of Yeast Beta Glucan (Saccharomyces cerevisiae) compared to a placebo on cold and flu symptoms in an Adult Population – A double blind, randomised controlled trial.

This is a double blind, randomised, clinical study with a 3-month participation and 2 groups (1 active ingredient group and 1 inactive placebo group). Saccharomyces cerevisiae is approved as an ingredient for use in Listed medicines on the ARTG (ingredient ID 79258). Once enrolled in the study, participants will be randomly allocated to either a placebo group or an active intervention group. Following enrolment, participants will receive the trial product in the mail. Upon receiving the trial product, participants will register their start of trial product using a provided link to a secure, personalised login and then be asked to start consuming the allocated study product according to the dose prescribed (1 x 200 mg oral capsule daily). Following the start of the trial product, participants will be contacted electronically (text message and email) fortnightly to confirm they are still enrolled, still taking product as prescribed, if they have experienced any cold or flu symptoms (unless an event has been logged) or experienced any adverse events. During the 3-month study period, participants will be asked to complete a SF-8 questionnaire every 4-weeks. Additionally, if a participant experiences the onset of cold or flu symptoms (e.g. cough, sneezing, stuffy or runny nose, fever, scratchy or sore throat and nasal breathing), participants will then be required to record their daily symptoms (including the severity) online using the WURSS-24 questionnaire for the duration of the event. If a participant’s symptoms continue for more that 2-weeks, they will be asked to seek medical advice (GP). If the GP thinks it is still just a cold or flu, at the discretion of the GP, the participant may continue to take the trial product if medication is not required. Once the participant has had a 2-week symptom free period, they may still log subsequent events within the trial period. Once symptoms of an event have subsided, participants are asked to continue to take the trial product for the remaining duration of the study period (up to 3-months total) and record any subsequent cold or flu episodes provided they have been symptom free for at least 2-weeks. At the end of the 3 months, participation in the study will be considered complete regardless of if a cold or flu event has been logged or not. Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.