Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001368123
Ethics application status
Approved
Date submitted
19/09/2019
Date registered
8/10/2019
Date last updated
19/05/2022
Date data sharing statement initially provided
8/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Palmitoylethanolamide (PEA) supplementation on the symptoms of allergic rhinitis - A double-blind placebo controlled trial.
Scientific title
The effect of Palmitoylethanolamide (PEA) supplementation on the symptoms of allergic rhinitis - A double-blind placebo controlled trial.
Secondary ID [1] 299338 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic rhinitis 314484 0
Condition category
Condition code
Inflammatory and Immune System 312817 312817 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315607 0
Treatment: Other
Comparator / control treatment
The placebo product will be maltodextrin encapsulated in an opaque capsule. It will appear identical to the test products. It will be administered as two capsules containing maltodextrin taken daily in the morning.
Control group
Placebo

Outcomes
Primary outcome [1] 321455 0
Change in allergy symptoms - Reflective total nasal symptom score 12 hour (TOTAL rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose.
Timepoint [1] 321455 0
Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3
Secondary outcome [1] 375009 0
Reflective individual nasal symptom scores (Individual rTNSS)
Timepoint [1] 375009 0
Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3
Secondary outcome [2] 375010 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score
Timepoint [2] 375010 0
Baseline & Week 3
Secondary outcome [3] 375011 0
Change in biochemistry markers from baseline as assessed by serum assay - cytokines, hs-CRP, FBC, histamine, E/LFT
Timepoint [3] 375011 0
Baseline & Week 3
Secondary outcome [4] 375012 0
Onset of action (when did symptoms start to improve) by analysis of reflective total nasal symptom score 12 hour (TOTAL rTNSS).
Timepoint [4] 375012 0
Baseline, Treatment weeks 1-3 twice daily (am & pm), Week 3

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/09/2019
Date of last participant enrolment
Anticipated
31/05/2021
Actual
12/01/2022
Date of last data collection
Anticipated
30/06/2021
Actual
11/02/2022
Sample size
Target
156
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303855 0
Commercial sector/Industry
Name [1] 303855 0
Gencor Pacific
Country [1] 303855 0
China
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 303986 0
Commercial sector/Industry
Name [1] 303986 0
Pharmako Biotechnologies Pty Ltd,
Address [1] 303986 0
Campbell Ave Cromer, NSW
2099
Country [1] 303986 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304367 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 304367 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 304367 0
Australia
Date submitted for ethics approval [1] 304367 0
29/05/2019
Approval date [1] 304367 0
11/09/2019
Ethics approval number [1] 304367 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96706 0
Dr David Briskey
Address 96706 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 96706 0
Australia
Phone 96706 0
+61 421 784 077
Fax 96706 0
Email 96706 0
[email protected]
Contact person for public queries
Name 96707 0
Amanda Rao
Address 96707 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 96707 0
Australia
Phone 96707 0
+61 414 488 559
Fax 96707 0
Email 96707 0
[email protected]
Contact person for scientific queries
Name 96708 0
Amanda Rao
Address 96708 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 96708 0
Australia
Phone 96708 0
+61 414 488 559
Fax 96708 0
Email 96708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4978Ethical approval    378412-(Uploaded-19-09-2019-14-07-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Levagen+ (Palmitoylethanolamide) Supplementation on Symptoms of Allergic Rhinitis-A Double-Blind Placebo-Controlled Trial.2023https://dx.doi.org/10.3390/nu15234940
N.B. These documents automatically identified may not have been verified by the study sponsor.