None listed
Conditions
Brief summary
The aim of this study is to assess the effect of orally-dosed palmitoylethanolamide (PEA) on allergy symptoms in otherwise healthy young males and females aged over 18 years compared to a placebo. This is a double-blind, randomised, clinical trial with a 2-week treatment duration with 2 arms. It is hypothesised that PEA supplementation over a period of 2 weeks will reduce the severity of allergy symptoms compared to the placebo.
Interventions
The intervention is Palmitoylethanolamide (PEA).
Each dose will contain 350 mg of PEA with a dispersion technology LipiSperse™.
Each product will be consumed as per the following: Two capsules containing a total 350 mg of PEA with LipiSperse™ and maltodextrin taken daily in the morning for 2 weeks.
Adherence will be monitored by product return at the completion of participation.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and females over 18 years old Reporting seasonal allergic rhinitis Generally healthy Able to provide informed consent Females using a prescribed form of birth control birth control, abstinent or post-menopausal Agree not to change current diet/exercise or not to use other supplements/products for allergy relief other than the test product during study period. A score of 3 or more on at least 4 of the 7 baseline days for the 24 hour score on the rTNSS # # Participants will undertake 7 days of rTNSS and continue to take supplement once they fulfil the rTNSS score requirement.
Exclusion criteria
Unstable or serious illness (e.g. MS, kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy) including mental/mood disorders (e.g. depression and bipolar)* Malignancy or treatment for malignancy within the previous 2 years Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy Active smokers, nicotine, alcohol, drug abuse Chronic past and/or current alcohol use (consumption of more than 14 standard alcoholic drinks per week) Allergic to any of the ingredients in active or placebo formula Pregnant or lactating woman § Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * 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. § Participants who have any reason to feel there is any possibility they are pregnant will be offered a pregnancy test to undertake before continuing.
Outcome results
None listed