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.
RDC Global Pty Ltd
300 participants
Jul 20, 2020
Interventional
Conditions
Summary
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. The aim of this study is to assess the effectiveness of PEA for reducing incidence and severity of URTI symptoms compared to a placebo in otherwise healthy adults aged 18-65 years old.
Eligibility
Inclusion Criteria3
- Male and females aged 18-65 years old
- Able to provide informed consent
- Agree not to take other supplements (e.g. Echinacea, Vitamin C, zinc) or medications (e.g. Tamiflu, Relenza) aimed at preventing URTIs for the duration of the trial (3 months).
Exclusion Criteria13
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions or chronic asthma)*
- Acute sickness experienced in the past 2 months
- Serious mood disorders or neurological disorders such as MS
- Active smokers and/or nicotine or drug abuse
- Chronic alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula
- Pregnant or lactating woman
- People medically prescribed medications that would affect the immune and/or the inflammatory response.
- Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- Participants who have participated in any other related clinical study during the past 1 month
- People with cognitive damage
- People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12620000846921