Long-Term PEA Safety Study

Last updated: February 18, 2025
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Palmitoylethanolamide (PEA)

Placebo

Clinical Study ID

NCT06717867
LEVESS
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapytreatment 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 heartconditions

  • Unstable illness (e.g., diabetes and thyroid gland dysfunction)

  • History of renal function impairment

  • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or otheranticoagulation 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 illegalsubstances) abuse

  • Chronic past (within 12-months) and/or current alcohol use (>14 alcoholic drinksweek)

  • Pregnant or lactating women

  • Allergic, sensitive, or intolerant to any of the ingredients in active or placeboformula

  • Has a clinically significant abnormal finding on the medical assessment, medicalhistory, vital signs or clinical laboratory results at screening.

  • Participants who are currently participating in any other clinical trial or who haveparticipated in any other clinical trial during the past 1 month.

  • Any condition which in the opinion of the investigator makes the participantunsuitable for inclusion.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Palmitoylethanolamide (PEA)
Phase: 2
Study Start date:
January 22, 2025
Estimated Completion Date:
January 31, 2027

Study 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™).

Connect with a study center

  • RDC Clinical

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

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