None listed
Conditions
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.
Interventions
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
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.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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 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.
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)
Outcome results
None listed