STUDY ANNOUNCEMENT

SLEEP and STRESS Study

Are you aged over 18 years and experiencing stress and poor sleep?

Thank you for your interest in our study which is investigating the efficacy of three separate supplements in reducing the symptoms of poor sleep and stress.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

Why is this study being conducted?

Stress is a common and natural response to physical or psychological triggers, and it prepares the body to handle these challenges. Everyone experiences stress from time to time, however chronic unmanaged stress has been known to negatively affect mood and overall quality of life. Health issues can include anxiety, poor sleep, cardiovascular disease, weight gain and a weakened immune system.

Pharmaceutical treatment options for anxiety and poor sleep come with the risk of adverse effects and may be habit-forming, therefore there is a need for safe and effective non-pharmaceutical treatment options to be investigated.

How long is the study, and when does it start?

Your involvement in this study will be 8 weeks. We are recruiting on a rolling basis which means that your individual start date is flexible. Our clinic is open 6 days a week to allow for appointments between Mondays to Saturdays.

Please see below for more information. You can also register your interest using the form on this page.

About the product you’ll help investigate…

This study is designed to examine the effects of three different supplements compared to placebo in people experiencing stress and poor sleep.

  • Levagen+ is a supplement containing palmitoylethanolamide (PEA), which is a naturally occurring fatty acid derivative that has been shown to be useful for a variety of health conditions, including anxiety and sleep disturbances.
  • CPO Lavender Oil provides essential oil from the Lavender plant. Lavender oil has been used medicinally for centuries and is a well-known remedy for stress, sleep and anxiety.
  • Trpti is an Oleoylethanolamide (OEA) supplement. OEA is a fatty acid ethanolamide found in the body. Studies have shown that OEA supplementation may have several beneficial effects, particularly for inflammation, blood sugar control, weight loss, appetite control, and stress.

Trpti, CPO Lavender Oil and Levagen+ are vegan friendly.

The products will be provided in capsule form, and participants will be asked to take one capsule daily for 8 weeks.

As this study is placebo-controlled, you may or may not be allocated one of the active products. The products are allocated randomly on a chance basis, and you will not know which product group you have been allocated to. This is to ensure that no unintentional bias can impact the results.

In this study, there are 3 active groups and 1 placebo group, so you will have a 75% chance of receiving one of the active products.

Placebos are designed to look like the real product being studied except they do not contain the active ingredient. Using a placebo helps us to be confident that any effects we measure in the active group really are due to the active ingredient and not due to the body’s own reaction to a perceived treatment.

What is required of participants?

Your involvement in the study will be for 8 weeks.

During the study, you will be asked to:

  • Take the study product (in capsule form) once daily for 8 weeks.
  • Attend 2 appointments at the RDC Clinic in Brisbane.
  • Collect saliva samples for testing at the beginning and end of the study.
  • Complete a series of short online questionnaires and a Sleep Diary at 3 points during the study.

The information we collect during the study will enable the investigators to assess the product’s tolerability and effectiveness in improving the poor sleep, anxiety, perceived stress and well-being.  

To make the timings of these visits as convenient as possible for you, we are recruiting on a rolling basis. This means that your individual start date is flexible.

Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with detailed information will be provided to you before you are asked to give your consent to participate.

COMPENSATION

Upon completion of the study requirements, you will be paid $400. The payment will be made by gift voucher or via direct deposit to your nominated bank account (your choice) once all study requirements have been met.

Pro rata payments are also available in the case of early withdrawal.

If you are interested in participating, we’d love to hear from you. Please register your interest by answering the questionnaire and completing the form on this page…we’ll then get in touch to screen you for eligibility.

Check if you can register to take part…
    • Generally healthy adults aged 18 and over.
    • Able to provide informed consent.
    • Experiencing symptoms of stress and anxiety.
    • Experiencing poor sleep at least twice a week.
    • Able to commit to completing the study requirements

    Please register your interest by answering the questionnaire and completing the form on this page… we’ll then get in touch to screen you for suitability.

    Please note: This page is a summary of the study outline and participant requirements. A full Participant Information Sheet with more detailed information will be provided to you before you are asked to give your consent to participate.

    Ethics approval and privacy

    This RDC Clinical study has been approved by the Bellberry Human Research Ethics Committee under Approval Number: 2025-10-1648. The study is also registered on the clinicaltrials.gov under Registration Number: NCT07315516

    Trained trial coordinators will supervise your progress throughout the study. Your results will be made available to you at the conclusion of the study. Any of your personal information collected during the study will be kept in the strictest confidence.