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Lavender Essential Oil-based Product System for Sleep

NCT06510335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-07-22

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • dōTERRA International

    lead INDUSTRY

Principal Investigators

  • Nicole Stevens, PhD · doTERRA International

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-08-01
Completion
2023-08-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510335 on ClinicalTrials.gov