The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation. Participants will: * Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process. * Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study. * Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call. * During visits there will be safety assessments performed, blood sampling and questionnaires. The trial will include two participation modes: 1. In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility. 2. Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.
This is an interventional, phase II, randomised, double-blind, placebo-controlled, parallel dose safety study in healthy adults to assess long term population exposure to Palmitoylethanolamide (Levagen™).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
200
Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.
RDC Clinical
Brisbane, Queensland, Australia
Change from baseline to the end of the study period in participants with SAEs
Change from baseline to the end of the study period in: Number of participants with Serious Adverse Events (SAE) after first administration of study drug through to the last dose of study drug plus 2 weeks \[time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)\]
Time frame: From Day O (Baseline) to 54 weeks
Change from baseline to month 12 in AEs
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in all adverse events (AEs)
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in medical assessment
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Medical assessment (by a doctor). The Medical Assessment is a medical review to elucidate symptoms of any occult medical conditions will be conducted for all participants and a medical assessment will then be performed. The assessment will include a review of vital signs and measurements, general appearance, brief cranial nerve assessment, cardiovascular, gastrointestinal and respiratory assessments. Other body systems will be examined (e.g. neurological, renal, musculoskeletal, ear, nose and throat or skin) as is deemed necessary by the trial doctor as guided by the medical review.
Time frame: Baseline (day 0) and Month 12
Change from baseline to month 12 in Vital Signs (blood pressure)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by blood pressure (mmHg).
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Vital Signs (heart rate)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by heart rate (bpm).
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by Full Blood Count (FBC).
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by fasting glucose.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (insulin)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by insulin.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (lipids).
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by lipids.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by electrolytes.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by kidney function tests.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by liver function tests.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in sleep questionnaires.
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Leeds sleep evaluation questionnaire (LSEQ). Each domain of the LSEQ is scored using a visual analogue scale (VAS) where participants mark their response on a line ranging from 0 to 100. Higher scores indicate better sleep quality or easier sleep-related behaviors in the respective domain. Lower scores indicate poorer sleep quality or more difficulty in the respective domain.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in anxiety questionnaires
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Anxiety questionnaires (Beck Anxiety Inventory Scale). Scores from 0 to 63, a score of 0-21 indicates low anxiety whereas a score of 36 and above indicates potentially concerning levels of anxiety.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Quality of life
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Quality of life (RAND 36-Item Short Form Survey Instrument, Rand SF-36).
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Musculoskeletal health questionnaire
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Musculoskeletal health questionnaire (MSK-HQ). MSK-HQ is scored on a range of 0-56, with a better score indicating better MSK-HQ health status.
Time frame: Baseline (Day 0) to month 12.
Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Gastrointestinal tolerance questionnaire
Time frame: Baseline (Day 0) to month 12.
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