NCT06510335

Lavender Essential Oil-based Product System for Sleep

Evaluation of a Lavender-based Natural Product System for Sleep Support

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: dōTERRA International · Industry
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn whether lavender essential oil-based product system can affect gene expression, serum protein markers, and sleep quality in healthy volunteers. The main questions this study aims to answer are: * Does the lavender essential oil-based product system affect gene expression and protein markers as measured in blood? * Does the lavender essential oil-based product system affect subjective quality of life and sleep assessments? * Is daily use of the product system safe, as measured by laboratory tests and adverse events? The lavender essential oil-based product system contains three components: an essential oil blend, a topical stick, and a dietary supplement. Participants will: * Receive a fitness tracker to monitor their sleep and physical activity. * Use the lavender essential oil-based product system for six weeks total according to this schedule: * 1 week: Essential oil blend * 1 week: Essential oil blend + topical stick * 4 weeks: Essential oil blend + topical stick + dietary supplement * Attend two study visits in which they provide blood and urine samples, and complete subjective sleep and quality of life assessments * Complete weekly subjective sleep assessments from home

Detailed description

This single-blind study will recruit healthy men and women to compare gene expression profile and serum protein markers before and after consumption of sleep system products for 6 weeks. Quality of life and sleep quality will be assessed using subjective surveys and questionnaires. Safety markers (liver and kidney function, hematology, urinalysis, and adverse events) will be collected.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Lavender essential oil-based product system	Participants used the study products in a sequential, additive manner approximately 30-60 minutes before bedtime each night for 6 weeks. Usage consists of the following: * 20 drops of essential oil blend in approximately 250 mL of water in a diffuser, which operated for 8 hours at nighttime. * 3 x 6" swipes of the topical stick on the upper chest area, and 2 x 3" swipes on the inside of each wrist for topical application. * 2 capsules of the dietary supplement. Participants used the essential oil blend alone for 1 week, then added the topical stick for another 1 week. Finally, participants used the essential oil blend, the topical stick, and the dietary supplement for four weeks.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-08-01
• Completion: 2023-08-11
• First posted: 2024-07-19
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States