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

What this Trial Is About

Researchers are evaluating the effects of natural supplements—lavender oil, palmitoylethanolamide (PEA), and oleoylethanolamide (OEA)—on improving sleep quality and reducing stress and anxiety in adults with moderate stress levels and sleep difficulties. This phase 2 randomized, double-blind, placebo-controlled trial aims to understand how these supplements work and their safety when taken daily. The study involves 240 adults with a Perceived Stress Scale (PSS) score of 14 or higher and sleep complaints occurring at least twice a week. Participants are randomly assigned to one of four groups: lavender oil, PEA, OEA, or a placebo group. Each participant takes one capsule daily for 8 weeks (57 days). The active supplements and placebo capsules look identical to maintain blinding. The study uses validated questionnaires and collects saliva samples to assess stress, sleep patterns, and hormone levels throughout the intervention. During the study, participants attend two clinic visits and have a phone check-in between visits. Researchers monitor stress, anxiety, sleep quality, mood, and mental wellbeing using questionnaires from day 1 to day 57. They also measure sleep duration, sleep onset latency, sleep efficiency, daytime sleepiness, and stress-related eating. Safety is assessed by tracking adverse events and vital signs like blood pressure, heart rate, oxygen saturation, and temperature. The total participation lasts for the 8-week intervention period.

Sleep and Stress Study