About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults (18 years and older)
Generally healthy
Able to provide informed consent
BMI 18.5 - 35.0 kg/m2
Disqualifiers
Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
Serious illness e.g., mood disorders (such as depression or bipolar disorder), anxiety, neurological disorders (such as MS), kidney disease, liver disease or heart conditions
Unstable illness (e.g., diabetes and thyroid gland dysfunction)
History of renal function impairment
Trial design
Parallel
Treatments tested in this trial
Palmitoylethanolamide (PEA)
Dietary supplementLevagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
Placebo
Other interventionPlacebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.
Treatment groups
Trial outcomes
Primary outcomes
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 \[time frame: after first administration of study drug through to the last dose of study drug (12 months) plus 2 weeks (week 54)\]
Secondary outcomes
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)
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.
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).
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).
Other outcomes
Exploratory: Change from baseline to month 12 in Vital Signs (temperature)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by temperature (celcius).
Exploratory: Change from baseline to month 12 in Vital Signs (O2 saturation)
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in safety monitored by O2 saturation (%).
Exploratory: Change from baseline to month 12 in PEA
Change from baseline (Day 0, Visit 1) to the end of the study period (month 12, Visit 6) in PEA plasma concentration over time
Exploratory: Change from baseline to month 12 in serum BDNF, CRP, and cytokines
Change from baseline (Day 0) to the end of the study period (month 12) in safety monitored by Serum BDNF, CRP, and cytokines (e.g., IL-1b, IL-6, IL-10, TNF-a)\]
Sponsors and contacts
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RDC Clinical Pty Ltd
Lead sponsor
Gencor Pacific Limited, Hong Kong
Collaborator