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Trial registered on ANZCTR


Registration number
ACTRN12618001339246
Ethics application status
Approved
Date submitted
3/07/2018
Date registered
9/08/2018
Date last updated
16/04/2021
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study.
Scientific title
Effect of LEVAGEN CWD palmitoylethanolamide (PEA) supplement on sleep quality/quantity in a healthy adult population: A double-blind randomized placebo-controlled interventional study
Secondary ID [1] 295408 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SLE-PEA18
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 308970 0
Condition category
Condition code
Neurological 307583 307583 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Palmitoylethanolamide (PEA) is the intervention.

Each dose will contain 350mg (2 x 175 mg) of Levagen CWD PEA. Each 175 mg capsule contains 157.5 mg of PEA and 17.5 mg of excipient (maltodextrin).

Each product will be consumed as per the following: Two capsules containing 175mg of PEA and maltodextrin with water one hour prior to sleep onset for 8 weeks duration. PEA is also approved for sale as a food for special medical purposes.

Compliance will be monitored via capsule return at the end of the study.
Intervention code [1] 301715 0
Treatment: Drugs
Comparator / control treatment
The placebo product will contain maltodextrin encapsulated in an opaque vegetable capsule and will appear identical to the interventional product.

The placebo dosed one hour prior to sleep onset for 8 weeks.

Compliance will be monitored via capsule return at the end of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 306561 0
Sleep quality measured by Pittsburgh sleep quality survey
Timepoint [1] 306561 0
Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention
Primary outcome [2] 306845 0
Sleep quantity measured by Pittsburgh sleep quality survey
Timepoint [2] 306845 0
Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention
Secondary outcome [1] 348876 0
Change in weight measured by scale weight
Timepoint [1] 348876 0
Baseline and week 8
Secondary outcome [2] 348877 0
Change in waist circumference measured by tape measure
Timepoint [2] 348877 0
Baseline and week 8
Secondary outcome [3] 348878 0
Body mass index as measured by calculating weight using a scale and height using a stadiometer
Timepoint [3] 348878 0
Baseline and week 8
Secondary outcome [4] 348879 0
Change in sleep onset time as measured by consensus sleep diary
Timepoint [4] 348879 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [5] 348880 0
Change in sleep pattern disturbance as measured by Pittsburgh sleep quality survey
Timepoint [5] 348880 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [6] 348881 0
Morning grogginess on waking measured using the Sleep inertia questionnaire
Timepoint [6] 348881 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [7] 348882 0
Change in nap count as measured by Pittsburgh sleep quality survey
Timepoint [7] 348882 0
Baseline, Day 5, weeks, 2, 4 8 and 10
Secondary outcome [8] 348883 0
Change in inflammatory markers - TNF-a, IL-6, IL-8, IL-10, hs-CRP, PEA concentration measured via blood serum
Timepoint [8] 348883 0
Baseline and week 8
Secondary outcome [9] 348884 0
General safety markers as measured by ELF/T serum test
Timepoint [9] 348884 0
Baseline and week 8
Secondary outcome [10] 348885 0
Gastrointestinal tolerance as measured by the 'Gastrointestinal Tolerance Questionnaire'
Timepoint [10] 348885 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [11] 348886 0
Quality of life as measured by SF-36 questionnaire
Timepoint [11] 348886 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [12] 349911 0
Primary outcome: Sleep quality measured by wrist actigraphy
Timepoint [12] 349911 0
Baseline, day 5, weeks, 2, 4 and 8 (primary endpoint) post start of intervention
Secondary outcome [13] 349912 0
Primary outcome: Sleep quantity measured by wrist actigraphy
Timepoint [13] 349912 0
Baseline, day 5, weeks, 2, 4 and 8 (primary endpoint) post start of intervention
Secondary outcome [14] 349913 0
change in nap duration as measured by Pittsburgh sleep quality survey,
Timepoint [14] 349913 0

Baseline, Day 5, weeks, 2, 4 8 and 10
Secondary outcome [15] 350430 0
change in hip circumference as measured by tape measure
Timepoint [15] 350430 0
Baseline and week 8
Secondary outcome [16] 350431 0
change in waist hip ratio as measured by tape measure
Timepoint [16] 350431 0
Baseline and week 8
Secondary outcome [17] 350432 0
Change in sleep pattern disturbance as measured by Epworth sleepiness scale
Timepoint [17] 350432 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [18] 350433 0
Change in sleep pattern disturbance as measured by Consensus sleep diary
Timepoint [18] 350433 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [19] 350434 0
Change in sleep pattern disturbance as measured by PROMIS sleep disturbance scale
Timepoint [19] 350434 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [20] 350435 0
Change in sleep pattern disturbance as measured by Sleep Interia Questionnaire
Timepoint [20] 350435 0
Baseline, day 5, weeks 2, 4, 8 and 10
Secondary outcome [21] 350436 0
Change in sleep pattern disturbance as measured by wrist actigraphy
Timepoint [21] 350436 0
Baseline, day 5, weeks 2, 4 and week 8
Secondary outcome [22] 350437 0
Change in nap count as measured by Epworth sleepiness scale
Timepoint [22] 350437 0
Baseline, Day 5, weeks, 2, 4 8 and 10
Secondary outcome [23] 350438 0
Change in nap count as measured by
consensus sleep diary
Timepoint [23] 350438 0
Baseline, Day 5, weeks, 2, 4 8 and 10
Secondary outcome [24] 350479 0
change in nap duration as measured by consensus sleep diary
Timepoint [24] 350479 0
Baseline, Day 5, weeks, 2, 4 8 and 10
Secondary outcome [25] 373736 0
Change in morning grogginess on waking as measured by Sleep inertia questionnaire
Timepoint [25] 373736 0
Baseline, Day 5 Week 2, 4, 8 & 10

Eligibility
Key inclusion criteria
Male and females over 18 years old
Disturbed sleeping pattern
Generally healthy
Able to provide informed consent
Females on a prescribed form of birth control
Agree not to change current diet/exercise or not to use other dietary supplements other than the test product during entire study period.
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. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function Malignancy)
Regular sleeping pattern
Malignancy or treatment for malignancy within the previous 2 years
Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy
Receiving/prescribed sleep medication/aid
Sleep apnea
Diagnosed or consistent gastrointestinal issues that disrupt sleep
Active smokers, nicotine, alcohol, drug abuse
Chronic past and/or current alcohol use (>14 alcoholic drinks week)
Allergic to any of the ingredients in active or placebo formula
People with serious mood disorders (such as depression and bipolar disorder) will be excluded. The Depression, Anxiety, Stress scale could be used as a screening form to ensure that those with undiagnosed depression are not enrolled into the study
Those suffering from insomnia or have night-shift employment and unable to have a normal night’s sleep
People suffering any neurological disorders such as MS
Pregnant or lactating woman
Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
Participants who have participated in any other related clinical trial during the past 1 month
Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
History of infection in the month prior to the study
Regularly taking stimulants (e.g. coffee, caffeine supplements, caffeine containing beverages) from midday onwards
Disturbed sleeping pattern caused by external factors (e.g. children, partner, noises)

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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/11/2018
Actual
17/04/2019
Date of last participant enrolment
Anticipated
Actual
12/08/2020
Date of last data collection
Anticipated
Actual
25/09/2020
Sample size
Target
120
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299996 0
Commercial sector/Industry
Name [1] 299996 0
Gencor Pacific
Country [1] 299996 0
Hong Kong
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] 299380 0
Commercial sector/Industry
Name [1] 299380 0
Pharmako Biotechnologies Pty Ltd
Address [1] 299380 0
36 Campbell Ave, Cromer NSW 2099
Country [1] 299380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300850 0
Bellberry Human Research Ethics Committee A Committee
Ethics committee address [1] 300850 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300850 0
Australia
Date submitted for ethics approval [1] 300850 0
04/09/2018
Approval date [1] 300850 0
05/03/2019
Ethics approval number [1] 300850 0

Summary
Brief summary
This is a double-blind, randomised, clinical trial with a 2-month treatment duration with 2 arms (1 active ingredient arm and 1 placebo arm).

Participants will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study.

Once enrolled in the trial, participants will be randomly allocated to either the placebo group or the active intervention groups. Briefly, participants will have baseline measurements performed and receive a 2-month supply of the study product. Baseline testing includes: several questionnaires (Pittsburgh sleep quality survey, Epworth sleepiness scale, PROMIS sleep disturbance, self-assessment of sleep quality, Consensus sleep diary, SF-36, GI tolerance), anthropometry measures (weight, height, BMI, waist/hip circumference), 20 mL blood sample (TNF-a, IL-6, IL-8, IL-10, hs-CRP, PEA concentration, ELF/T) and wrist actigraphy (3 days wearing a Polar A370).

Participants will be asked to consume the allocated product according to the dose prescribed (350 mg/day PEA or placebo). An opaque bottle containing opaque vegetable capsules will be provided to each participant according to their group allocation. Participants will then return at timepoint: 8 weeks for subsequent testing. At the 8-week time points, the testing will be a repeat of baseline measurements. At 5 days, 2 and 4 weeks the participants will complete the same testing except for any blood markers and anthropometry measurements. Two weeks after treatment cessation participants will be asked to complete questionnaires again online.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85030 0
Dr David Briskey
Address 85030 0
RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85030 0
Australia
Phone 85030 0
+61 421 784 077
Fax 85030 0
Email 85030 0
[email protected]
Contact person for public queries
Name 85031 0
Amanda Rao
Address 85031 0
RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85031 0
Australia
Phone 85031 0
+61 414 488 559
Fax 85031 0
Email 85031 0
[email protected]
Contact person for scientific queries
Name 85032 0
Amanda Rao
Address 85032 0
RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
Country 85032 0
Australia
Phone 85032 0
+61 414 488 559
Fax 85032 0
Email 85032 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
No IPD will be shared


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2046Ethical approval    375493-(Uploaded-10-05-2019-08-59-55)-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
No additional documents have been identified.