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.

Overview

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.

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™).

Interventions

• Dietary supplement Palmitoylethanolamide (PEA)
  Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.
• Other Placebo
  Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.

Primary outcome measures

• Change from baseline to the end of the study period in participants with SAEs [Time frame: From Day O (Baseline) to 54 weeks]

Secondary outcome measures (12)

• Change from baseline to month 12 in AEs [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in medical assessment [Time frame: Baseline (day 0) and Month 12]
• Change from baseline to month 12 in Vital Signs (blood pressure) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in Vital Signs (heart rate) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (fasting glucose) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (insulin) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (lipids). [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (electrolytes) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (kidney function tests) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in clinical laboratory determinations (Liver function tests) [Time frame: Baseline (Day 0) to month 12.]
• Change from baseline to month 12 in sleep questionnaires. [Time frame: Baseline (Day 0) to month 12.]

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, 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Australia · 1 center

• RDC Clinical — Brisbane

Identifiers

NCT: NCT06717867 · LEVESS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗