Effect of Palmitoylethanolamide (PEA) compared to a placebo on symptoms for upper respiratory tract infection (URTI) in an Adult Population – A double blind, randomised controlled trial.

PEA is a TGA approved ingredient for use in listed medicines in Australia (Brand name Levagen+). Palmitoylethanolamide (PEA) as Levagen+ will be taken as 2 x 300 mg capsules per day – 1 capsule in the morning, 1 capsule in the evening for the duration of the intervention period (3 months). 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 URTI 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 or up to 2-weeks. Participants are required to continue taking their study product while they are experiencing symptoms. If a participant’s symptoms continue for more than 2-weeks, they will be asked to stop recording the event and seek medical advice (GP). 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 URTI episodes. Adherence will be monitored by return and logging of any remaining study product at completion of intervention period.