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Healthy volunteers needed to test safety of popular supplement over 12 months

NCT ID NCT06717867

Knowledge-focused Sponsor: RDC Clinical Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study is checking if taking a supplement called palmitoylethanolamide (PEA) every day for a year is safe for healthy adults. About 200 volunteers aged 18 and older will take either PEA or a placebo pill. Researchers will track side effects, vital signs, and blood tests over 12 months. This trial does not aim to treat any disease—it only looks at safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy SAFETY

Contacts and locations

Locations

  • RDC Clinical

    Brisbane, Queensland, 4006, Australia

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