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Trial Review
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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
Date results information initially provided
16/04/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study.
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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
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Secondary ID [1]
295408
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
SLE-PEA18
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance
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Condition category
Condition code
Neurological
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
301715
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Treatment: Drugs
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Sleep quality measured by Pittsburgh sleep quality survey
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Assessment method [1]
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Timepoint [1]
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Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention
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Primary outcome [2]
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Sleep quantity measured by Pittsburgh sleep quality survey
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Assessment method [2]
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Timepoint [2]
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Baseline, day 5, weeks 2, 4, 8 and 10 (primary endpoint) post start of intervention
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Secondary outcome [1]
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Change in weight measured by scale weight
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Assessment method [1]
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Timepoint [1]
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Baseline and week 8
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Secondary outcome [2]
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Change in waist circumference measured by tape measure
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Assessment method [2]
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Timepoint [2]
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Baseline and week 8
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Secondary outcome [3]
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Body mass index as measured by calculating weight using a scale and height using a stadiometer
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Assessment method [3]
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Timepoint [3]
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Baseline and week 8
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Secondary outcome [4]
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Change in sleep onset time as measured by consensus sleep diary
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Assessment method [4]
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Timepoint [4]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [5]
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Change in sleep pattern disturbance as measured by Pittsburgh sleep quality survey
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Assessment method [5]
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Timepoint [5]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [6]
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Morning grogginess on waking measured using the Sleep inertia questionnaire
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Assessment method [6]
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Timepoint [6]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [7]
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Change in nap count as measured by Pittsburgh sleep quality survey
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Assessment method [7]
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Timepoint [7]
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Baseline, Day 5, weeks, 2, 4 8 and 10
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Secondary outcome [8]
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Change in inflammatory markers - TNF-a, IL-6, IL-8, IL-10, hs-CRP, PEA concentration measured via blood serum
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Assessment method [8]
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Timepoint [8]
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Baseline and week 8
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Secondary outcome [9]
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General safety markers as measured by ELF/T serum test
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Assessment method [9]
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Timepoint [9]
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Baseline and week 8
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Secondary outcome [10]
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Gastrointestinal tolerance as measured by the 'Gastrointestinal Tolerance Questionnaire'
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Assessment method [10]
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Timepoint [10]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [11]
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Quality of life as measured by SF-36 questionnaire
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Assessment method [11]
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Timepoint [11]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [12]
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Primary outcome: Sleep quality measured by wrist actigraphy
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Assessment method [12]
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Timepoint [12]
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Baseline, day 5, weeks, 2, 4 and 8 (primary endpoint) post start of intervention
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Secondary outcome [13]
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Primary outcome: Sleep quantity measured by wrist actigraphy
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Assessment method [13]
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Timepoint [13]
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Baseline, day 5, weeks, 2, 4 and 8 (primary endpoint) post start of intervention
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Secondary outcome [14]
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change in nap duration as measured by Pittsburgh sleep quality survey,
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Assessment method [14]
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Timepoint [14]
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Baseline, Day 5, weeks, 2, 4 8 and 10
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Secondary outcome [15]
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change in hip circumference as measured by tape measure
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Assessment method [15]
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Timepoint [15]
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Baseline and week 8
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Secondary outcome [16]
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change in waist hip ratio as measured by tape measure
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Assessment method [16]
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Timepoint [16]
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Baseline and week 8
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Secondary outcome [17]
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Change in sleep pattern disturbance as measured by Epworth sleepiness scale
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Assessment method [17]
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Timepoint [17]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [18]
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Change in sleep pattern disturbance as measured by Consensus sleep diary
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Assessment method [18]
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Timepoint [18]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [19]
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Change in sleep pattern disturbance as measured by PROMIS sleep disturbance scale
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Assessment method [19]
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Timepoint [19]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [20]
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Change in sleep pattern disturbance as measured by Sleep Interia Questionnaire
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Assessment method [20]
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Timepoint [20]
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Baseline, day 5, weeks 2, 4, 8 and 10
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Secondary outcome [21]
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Change in sleep pattern disturbance as measured by wrist actigraphy
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Assessment method [21]
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Timepoint [21]
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Baseline, day 5, weeks 2, 4 and week 8
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Secondary outcome [22]
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Change in nap count as measured by Epworth sleepiness scale
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Assessment method [22]
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Timepoint [22]
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Baseline, Day 5, weeks, 2, 4 8 and 10
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Secondary outcome [23]
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Change in nap count as measured by
consensus sleep diary
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Assessment method [23]
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Timepoint [23]
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Baseline, Day 5, weeks, 2, 4 8 and 10
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Secondary outcome [24]
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change in nap duration as measured by consensus sleep diary
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Assessment method [24]
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Timepoint [24]
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Baseline, Day 5, weeks, 2, 4 8 and 10
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Secondary outcome [25]
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Change in morning grogginess on waking as measured by Sleep inertia questionnaire
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Assessment method [25]
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Timepoint [25]
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Baseline, Day 5 Week 2, 4, 8 & 10
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/11/2018
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Actual
17/04/2019
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Date of last participant enrolment
Anticipated
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Actual
12/08/2020
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Date of last data collection
Anticipated
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Actual
25/09/2020
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Sample size
Target
120
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Accrual to date
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Final
125
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Gencor Pacific
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Address [1]
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21-E, Elegance, Hillgrove Village
Discovery Bay, Hong Kong 999077
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Country [1]
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Hong Kong
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Primary sponsor type
Commercial sector/Industry
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Name
RDC Global Pty Ltd
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Address
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
Australia
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Secondary sponsor category [1]
299380
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Commercial sector/Industry
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Name [1]
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Pharmako Biotechnologies Pty Ltd
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Address [1]
299380
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36 Campbell Ave, Cromer NSW 2099
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Country [1]
299380
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee A Committee
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Ethics committee address [1]
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129 Glen Osmond Road Eastwood South Australia 5063
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
300850
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04/09/2018
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Approval date [1]
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05/03/2019
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Ethics approval number [1]
300850
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr David Briskey
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Address
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RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
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Australia
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Phone
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+61 421 784 077
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Amanda Rao
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Address
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RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
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Australia
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Phone
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+61 414 488 559
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Amanda Rao
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Address
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RDC Global
3B/76 Doggett Street
Newstead, QLD, 4006
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Country
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Australia
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Phone
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+61 414 488 559
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD will be shared
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
2046
Ethical 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.
Download to PDF