Sleep and stress relief with lavender, PEA, or OEA supplements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial will enroll 240 adults with moderate perceived stress (PSS ≥14) and regular sleep complaints and randomize them to one of four daily capsules (lavender oil, PEA, OEA, or placebo) for 8 weeks. Outcomes include validated sleep and stress questionnaires plus salivary biomarkers of HPA axis activity and circadian rhythm, with two clinic visits and one phone check-in. The study excludes people with severe insomnia or very low well-being and asks participants to avoid other sleep or stress supplements and not change diet or exercise during the study. Safety and adverse events will be monitored throughout to characterize tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Generally healthy adults aged 18 and over.
* Able to provide informed consent.
* Score of at least 14 on the Perceived Stress Scale (PSS).
* Those with a sleep complaint with a frequency of at least 2 times per week(1)
* Agree not to use other dietary supplements for sleep, depression, stress or anxiety other than the investigational product during entire study period.
* Agree not to change current diet and/or exercise frequency or intensity during entire study period.
* Agree to not participate in another clinical trial during the study period.

  1. Sleep complaints are defined as difficulty initiating sleep, or difficulty maintaining sleep, or early-morning awakening with inability to return to sleep and causing distress or impairment in social, occupational, educational, academic, behavioural, or other important areas of functioning.)

Exclusion Criteria:

* A WHO-5 Well-Being Index score ≤ 28
* Those with severe sleep complaints (Insomnia Severity Index \>21)
* Taking prescribed sleep, depression or anxiety medication
* Have a serious illness e.g. asthma, depression, anxiety disorder, bipolar disorder, insomnia, organic sleep disorders (i.e. sleep apnoea), neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Have an unstable illness e.g. diabetes and thyroid gland dysfunction
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks week)
* Those consuming more than 500mg caffeine per day
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* 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

Where it's running

• RDC Clinical
  Brisbane, Australia Recruiting

Study contacts

• Study coordinator: Amanda Rao, PhD
• Email: research@rdcglobal.com.au
• Phone: +61 (0) 7 3102 4486

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.