NCT07315516

Sleep and Stress Study

The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: RDC Clinical Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if natural supplements (lavender oil, PEA, and OEA) work to improve sleep and reduce stress in adults with moderate stress levels and sleep difficulties. It will also learn about the safety of these natural supplements. The main questions it aims to answer are: * Do these supplements improve sleep quality? * Do they reduce perceived stress levels? * Do they reduce anxiety symptoms? * What medical problems do participants have when taking these supplements? Researchers will compare three active treatment groups (lavender oil, PEA, Trpti which contains OEA) to a placebo (a look-alike capsule that contains no active ingredients) to see if these natural supplements work to improve sleep and reduce stress. Participants will take 1 capsule (either active supplement or placebo) every day for 8 weeks and attend 2 clinic visits with a phone check in in between.

Detailed description

The Effects of Natural Bioactive Compounds on Sleep and Stress: A Randomized Double-Blind Placebo-Controlled Trial This four-arm, parallel-group trial evaluates bioactive compounds targeting stress-sleep pathophysiology (lavender oil, PEA, and OEA). The 8-week intervention employs validated psychometric instruments alongside salivary biomarkers providing objective HPA axis and circadian rhythm assessment. The trial enrolls 240 participants (60 per arm) with moderate stress (PSS ≥14) and sleep complaints.

Conditions

• Sleep Disorder (Disorder)
• Stress
• Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lavender Oil	85mg CPO Lavender oil will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
DIETARY_SUPPLEMENT	Palmitoylethanolamide (PEA)	75mg Levagen+ PEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days.
DIETARY_SUPPLEMENT	Oleoylethanolamide	150mg Trpti OEA will be administered daily. This will be taken as a capsule, 1 capsule daily for 57 days
OTHER	Placebo	A placebo capsule containing microcrystalline cellulose will be taken daily, 1 capsule will be taken each day for 57 days.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: Australia