Clinical trial NCT06717867: Long-Term PEA Safety Study
Official title: A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Healthy
Safety
Keywords: Palmitoylethanolamide
PEA
Levagen
PEA Safety study
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Gencor Pacific Limited
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 attend 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 in clinic visits over 12 months. On months where participants do not attend the clinic there will be a check in phone call.
* During clinic visits there will be safety assessments performed, blood sampling and questionnaires.

Detailed description: 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™).

Eligibility criteria: Inclusion Criteria:

* Adults (18 years and older)
* Generally healthy
* Able to provide informed consent
* BMI 18.5 - 35.0 kg/m2
* Agree to not participate in another clinical trial during enrolment period

Exclusion Criteria:

* 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
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy \[(excluding low dose aspirin (under 300 mg/day)\]
* Regular consumption (\>4 times a week) of PEA over the past 2 weeks
* Substance Abuse (illicit and/or prescription) Drug (prescription or illegal substances) abuse
* Chronic past (within 12-months) and/or current alcohol use (\>14 alcoholic drinks week)
* Pregnant or lactating women
* Allergic, sensitive, or intolerant to any of the ingredients in active or placebo formula
* Has a clinically significant abnormal finding on the medical assessment, medical history, vital signs or clinical laboratory results at screening.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.

Primary outcomes:
measure: Change from baseline to the end of the study period in participants with SAEs
timeFrame: From Day O (Baseline) to 54 weeks
Secondary outcomes:
measure: Change from baseline to month 12 in AEs
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in medical assessment
timeFrame: Baseline (day 0) and Month 12
measure: Change from baseline to month 12 in Vital Signs (temperature)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Vital Signs (blood pressure)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Vital Signs (heart rate)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Vital Signs (oxygen saturation)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (insulin)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (lipids).
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in PEA
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in serum BDNF, CRP, and cytokines
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in sleep questionnaires.
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in anxiety questionnaires
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Quality of life
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Musculoskeletal health questionnaire
timeFrame: Baseline (Day 0) to month 12.
measure: Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
timeFrame: Baseline (Day 0) to month 12.
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical
state: Queensland
Study officials:
References: