Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06717867




Registration number
NCT06717867
Ethics application status
Date submitted
21/11/2024
Date registered
5/12/2024
Date last updated
16/12/2024

Titles & IDs
Public title
Long-Term PEA Safety Study
Scientific title
A Randomised, Double-blind Placebo-controlled Study in Healthy Adults to Assess Long Term Population Exposure to Palmitoylethanolamide (Levagen™) to Assess Clinical Safety.
Secondary ID [1] 0 0
LEVESS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Safety 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Palmitoylethanolamide (PEA)
Other interventions - Placebo

Experimental: PEA (Levagen) - 600mg PEA each day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.

Placebo comparator: Placebo - 600mg microcrystalline cellulose a day. 1 oral capsule is taken twice per day after food, each capsule contains 300mg.


Treatment: Other: Palmitoylethanolamide (PEA)
Levagen™ capsule containing 300mg Palmitoylethanolamide (PEA). 600mg PEA per day.

Other interventions: Placebo
Placebo capsules contain 300 mg microcrystalline cellulose (MCC), 600mg per day.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to the end of the study period in participants with SAEs
Timepoint [1] 0 0
From Day O (Baseline) to 54 weeks
Secondary outcome [1] 0 0
Change from baseline to month 12 in AEs
Timepoint [1] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [2] 0 0
Change from baseline to month 12 in medical assessment
Timepoint [2] 0 0
Baseline (day 0) and Month 12
Secondary outcome [3] 0 0
Change from baseline to month 12 in Vital Signs (temperature)
Timepoint [3] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [4] 0 0
Change from baseline to month 12 in Vital Signs (blood pressure)
Timepoint [4] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [5] 0 0
Change from baseline to month 12 in Vital Signs (heart rate)
Timepoint [5] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [6] 0 0
Change from baseline to month 12 in Vital Signs (oxygen saturation)
Timepoint [6] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [7] 0 0
Change from baseline to month 12 in clinical laboratory determinations (Full Blood Count)
Timepoint [7] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [8] 0 0
Change from baseline to month 12 in clinical laboratory determinations (fasting glucose)
Timepoint [8] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [9] 0 0
Change from baseline to month 12 in clinical laboratory determinations (insulin)
Timepoint [9] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [10] 0 0
Change from baseline to month 12 in clinical laboratory determinations (lipids).
Timepoint [10] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [11] 0 0
Change from baseline to month 12 in clinical laboratory determinations (electrolytes)
Timepoint [11] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [12] 0 0
Change from baseline to month 12 in clinical laboratory determinations (kidney function tests)
Timepoint [12] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [13] 0 0
Change from baseline to month 12 in clinical laboratory determinations (Liver function tests)
Timepoint [13] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [14] 0 0
Change from baseline to month 12 in PEA
Timepoint [14] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [15] 0 0
Change from baseline to month 12 in serum BDNF, CRP, and cytokines
Timepoint [15] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [16] 0 0
Change from baseline to month 12 in sleep questionnaires.
Timepoint [16] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [17] 0 0
Change from baseline to month 12 in anxiety questionnaires
Timepoint [17] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [18] 0 0
Change from baseline to month 12 in Quality of life
Timepoint [18] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [19] 0 0
Change from baseline to month 12 in Musculoskeletal health questionnaire
Timepoint [19] 0 0
Baseline (Day 0) to month 12.
Secondary outcome [20] 0 0
Change from baseline to month 12 in Gastrointestinal tolerance questionnaire
Timepoint [20] 0 0
Baseline (Day 0) to month 12.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gencor Pacific Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06717867
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
RV Venkatesh
Address 0 0
Country 0 0
Phone 0 0
(852) 2987 6894
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06717867